Comparative Study of Sensitivity of Ga-DOTATOC PET vs Octreoscan SPECT + CT

Sponsor
Sue O'Dorisio (Other)
Overall Status
Completed
CT.gov ID
NCT01869725
Collaborator
National Cancer Institute (NCI) (NIH)
68
1
1
68.8
1

Study Details

Study Description

Brief Summary

This clinical trial studies gallium Ga 68-edotreotide positron emission tomography (PET)/computed tomography (CT) compared with indium In 111 pentetreotide plus contrast-enhanced CT (or MRI) in diagnosing patients with neuroendocrine tumors and other somatostatin receptor positive tumors. Diagnostic procedures, such as gallium Ga 68-edotreotide PET/CT, may help find and diagnose somatostatin receptor positive neuroendocrine tumors. It is not yet known whether Ga 68-edotreotide PET/CT is as effective as indium In 111 pentetreotide plus contrast-enhanced CT (or MRI) in diagnosis and staging of patients with neuroendocrine tumors.

Condition or Disease Intervention/Treatment Phase
  • Drug: gallium Ga 68-edotreotide
  • Procedure: positron emission tomography/computed tomography
  • Radiation: indium In 111 pentetreotide
  • Procedure: computed tomography
  • Procedure: contrast-enhanced magnetic resonance imaging
Phase 2

Detailed Description

PRIMARY OBJECTIVES:
  1. To compare efficacy of [68Ga]-DOTA-tyr3-Octreotide (68Ga-DOTATOC) (gallium Ga 68-edotreotide) PET/CT with Octreoscan (indium In 111 pentetreotide) + high-resolution, contrast-enhanced CT for diagnosis and staging in patients with somatostatin receptor expressing tumors.
OUTLINE:

Patients receive gallium Ga 68-edotreotide intravenously (IV) and undergo PET/CT scan. Within 120 days, patients undergo standard indium In 111 pentetreotide contrast-enhanced CT or MRI scan. Patients may also undergo a second gallium Ga 68-edotreotide PET/CT scan within 3-6 months if the lesions of the first scan cannot be confirmed.

Study Design

Study Type:
Interventional
Actual Enrollment :
68 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Comparator Study of 68Ga-DOTATOC PET/CT With Octreoscan + High-resolution, Contrast-enhanced CT for Diagnosis and Staging in Neuroendocrine Tumors and Other Somatostatin Receptor Positive Tumors
Actual Study Start Date :
Apr 1, 2013
Actual Primary Completion Date :
Dec 26, 2018
Actual Study Completion Date :
Dec 26, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Diagnostic (gallium Ga 68-edotreotide PET/CT)

Patients receive gallium Ga 68-edotreotide IV and undergo PET/CT scan. Within 120 days, patients undergo standard indium In 111 pentetreotide contrast-enhanced CT or MRI scan. Patients may undergo a second gallium Ga 68-edotreotide PET/CT scan within 3-6 months if the lesions of the first scan cannot be confirmed.

Drug: gallium Ga 68-edotreotide
Given IV
Other Names:
  • Ga-68 DOTA0-Tyr3-octreotide
  • Ga-68 DOTATOC
  • Procedure: positron emission tomography/computed tomography
    Undergo gallium Ga 68-edotreotide PET/CT scan

    Radiation: indium In 111 pentetreotide
    Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan
    Other Names:
  • Indium-111 Octreotide DTPA
  • Indium-111-DTPA-D-Phe-1-octreotide
  • Indium-In 111 Pentetreotide
  • Indium-In-111-Pentetreotide
  • Octreoscan
  • Procedure: computed tomography
    Undergo indium In 111 pentetreotide contrast-enhanced CT scan
    Other Names:
  • tomography, computed
  • Procedure: contrast-enhanced magnetic resonance imaging
    Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan
    Other Names:
  • Contrast-enhanced MRI
  • Outcome Measures

    Primary Outcome Measures

    1. Comparison of Conventional Imaging and Gallium Ga 68-edotreotide PET Using Concordance in Tumor Detection With Pathology [Up to 6 months between the timing of the Octreoscan SPECT/CT plus high-resolution, contrast-enhanced CT and the time of the 68Ga-DOTATOC PET/CT (either imaging type may occur first)]

      Tumor lesions detected on 68Ga-DOTATOC PET/CT compared with tumor lesions detected on Octreoscan SPECT imaging plus high-resolution, contrast-enhanced CT.

    2. Compare Sensitivity of 68Ga-DOTATOC PET/CT With Octreoscan [Up to 6 months]

      Compare sensitivity of 68Ga-DOTATOC PET/CT with Octreoscan + high-resolution, contrast-enhanced CT for diagnosis and staging in neuroendocrine tumors and other somatostatin receptor positive tumors

    3. Compare Specificity of 68Ga-DOTATOC PET/CT With Octreoscan [6 months]

      Compare specificity of 68Ga-DOTATOC PET/CT with Octreoscan + high-resolution, contrast-enhanced CT for diagnosis and staging in neuroendocrine tumors and other somatostatin receptor positive tumors

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Signed informed consent

    • Biopsy proven neuroendocrine tumor, neuroblastoma, medulloblastoma, or other somatostatin receptor positive tumor

    • Off Sandostatin (octreotide acetate)-long acting release (LAR) > 4 weeks and off immediate release (subcutaneous) for 12 hrs prior to 68Ga-DOTATOC PET-CT

    • Karnofsky performance status or Lansky Play Scale status of >= 50 (or Eastern Cooperative Oncology Group [ECOG]/World Health Organization [WHO] equivalent)

    • Subject is male; or is a female who is either pre-menarchal, surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (> 1 years without menses), non-lactating, or of childbearing potential for whom a serum pregnancy test (with the results known prior to investigational product administration) is negative; a negative serum pregnancy test will be required for all female subjects with child bearing potential; if a false pregnancy test is suspected, e.g., perimenopausal condition, an obstetrician will be consulted to determine if she is/is capable of becoming pregnant

    • No therapy other than Sandostatin since last Octreoscan + diagnostic CT

    • Fresh frozen (recommended) or paraffin fixed (required) specimen of primary or metastases available for ribonucleic acid (RNA) and immunohistochemistry (IHC)

    Exclusion Criteria:
    • Pregnancy or breast feeding

    • Surgical resection, chemotherapy, radiation therapy, or biologic therapy since last Octreoscan + CT; continuation of the same dose of Sandostatin-LAR or subcutaneous Sandostatin is allowed

    • Medical condition uncontrolled by treatment making completion of study unlikely

    • Weight more than 400 pounds (subjects who weigh more than 400 pounds will not be able to fit inside the imaging machines)

    • Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.)

    • Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)

    • Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the investigator, may significantly interfere with study compliance

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Iowa Hospitals and Clinics Iowa City Iowa United States 52242

    Sponsors and Collaborators

    • Sue O'Dorisio
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: M. Sue O' Dorisio, MD, PhD, University of Iowa

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Sue O'Dorisio, Principal Investigator, University of Iowa
    ClinicalTrials.gov Identifier:
    NCT01869725
    Other Study ID Numbers:
    • 201212736
    • NCI-2013-00936
    • P30CA086862
    • R01CA167632
    First Posted:
    Jun 5, 2013
    Last Update Posted:
    Sep 22, 2021
    Last Verified:
    Dec 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Sue O'Dorisio, Principal Investigator, University of Iowa
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Diagnostic (Gallium Ga 68-edotreotide PET/CT)
    Arm/Group Description Patients receive gallium Ga 68-edotreotide IV and undergo PET/CT scan. Within 120 days, patients undergo standard indium In 111 pentetreotide contrast-enhanced CT or MRI scan. Patients may undergo a second gallium Ga 68-edotreotide PET/CT scan within 3-6 months if the lesions of the first scan cannot be confirmed. gallium Ga 68-edotreotide: Given IV positron emission tomography/computed tomography: Undergo gallium Ga 68-edotreotide PET/CT scan indium In 111 pentetreotide: Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan computed tomography: Undergo indium In 111 pentetreotide contrast-enhanced CT scan contrast-enhanced magnetic resonance imaging: Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan
    Period Title: Overall Study
    STARTED 68
    COMPLETED 64
    NOT COMPLETED 4

    Baseline Characteristics

    Arm/Group Title Diagnostic (Gallium Ga 68-edotreotide PET/CT)
    Arm/Group Description Patients receive gallium Ga 68-edotreotide IV and undergo PET/CT scan. Within 120 days, patients undergo standard indium In 111 pentetreotide contrast-enhanced CT or MRI scan. Patients may undergo a second gallium Ga 68-edotreotide PET/CT scan within 3-6 months if the lesions of the first scan cannot be confirmed. gallium Ga 68-edotreotide: Given IV positron emission tomography/computed tomography: Undergo gallium Ga 68-edotreotide PET/CT scan indium In 111 pentetreotide: Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan computed tomography: Undergo indium In 111 pentetreotide contrast-enhanced CT scan contrast-enhanced magnetic resonance imaging: Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan
    Overall Participants 68
    Age (Count of Participants)
    <=18 years
    5
    7.4%
    Between 18 and 65 years
    45
    66.2%
    >=65 years
    18
    26.5%
    Age (years) [Mean (Full Range) ]
    Mean (Full Range) [years]
    55
    Sex: Female, Male (Count of Participants)
    Female
    33
    48.5%
    Male
    35
    51.5%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    Asian
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    Black or African American
    1
    1.5%
    White
    28
    41.2%
    More than one race
    1
    1.5%
    Unknown or Not Reported
    38
    55.9%
    Region of Enrollment (eligible participants) [Number]
    United States
    68
    100%

    Outcome Measures

    1. Primary Outcome
    Title Comparison of Conventional Imaging and Gallium Ga 68-edotreotide PET Using Concordance in Tumor Detection With Pathology
    Description Tumor lesions detected on 68Ga-DOTATOC PET/CT compared with tumor lesions detected on Octreoscan SPECT imaging plus high-resolution, contrast-enhanced CT.
    Time Frame Up to 6 months between the timing of the Octreoscan SPECT/CT plus high-resolution, contrast-enhanced CT and the time of the 68Ga-DOTATOC PET/CT (either imaging type may occur first)

    Outcome Measure Data

    Analysis Population Description
    Patients with neuroendocrine tumor or other somatostatin receptor positive tumor
    Arm/Group Title Diagnostic (Gallium Ga 68-edotreotide PET/CT)
    Arm/Group Description Patients receive gallium Ga 68-edotreotide IV and undergo PET/CT scan. Within 120 days, patients undergo standard indium In 111 pentetreotide contrast-enhanced CT or MRI scan. Patients may undergo a second gallium Ga 68-edotreotide PET/CT scan within 3-6 months if the lesions of the first scan cannot be confirmed. gallium Ga 68-edotreotide: Given IV positron emission tomography/computed tomography: Undergo gallium Ga 68-edotreotide PET/CT scan indium In 111 pentetreotide: Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan computed tomography: Undergo indium In 111 pentetreotide contrast-enhanced CT scan contrast-enhanced magnetic resonance imaging: Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan
    Measure Participants 34
    Total positive
    28
    41.2%
    False position
    0
    0%
    False negative
    1
    1.5%
    Total negative
    5
    7.4%
    Total positive
    23
    33.8%
    False position
    0
    0%
    False negative
    6
    8.8%
    Total negative
    5
    7.4%
    2. Primary Outcome
    Title Compare Sensitivity of 68Ga-DOTATOC PET/CT With Octreoscan
    Description Compare sensitivity of 68Ga-DOTATOC PET/CT with Octreoscan + high-resolution, contrast-enhanced CT for diagnosis and staging in neuroendocrine tumors and other somatostatin receptor positive tumors
    Time Frame Up to 6 months

    Outcome Measure Data

    Analysis Population Description
    Patients with neuroendocrine tumor or other somatostatin receptor positive tumor
    Arm/Group Title Diagnostic (Gallium Ga 68-edotreotide PET/CT)
    Arm/Group Description Patients receive gallium Ga 68-edotreotide IV and undergo PET/CT scan. Within 120 days, patients undergo standard indium In 111 pentetreotide contrast-enhanced CT or MRI scan. Patients may undergo a second gallium Ga 68-edotreotide PET/CT scan within 3-6 months if the lesions of the first scan cannot be confirmed. gallium Ga 68-edotreotide: Given IV positron emission tomography/computed tomography: Undergo gallium Ga 68-edotreotide PET/CT scan indium In 111 pentetreotide: Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan computed tomography: Undergo indium In 111 pentetreotide contrast-enhanced CT scan contrast-enhanced magnetic resonance imaging: Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan
    Measure Participants 34
    Sensitivity of Ga-68-DOTATOC
    96.55
    Sensitivity of OctreoScan
    79.31
    Sensitivity of Conventional Imaging (CI)
    82.24
    3. Primary Outcome
    Title Compare Specificity of 68Ga-DOTATOC PET/CT With Octreoscan
    Description Compare specificity of 68Ga-DOTATOC PET/CT with Octreoscan + high-resolution, contrast-enhanced CT for diagnosis and staging in neuroendocrine tumors and other somatostatin receptor positive tumors
    Time Frame 6 months

    Outcome Measure Data

    Analysis Population Description
    Patients with neuroendocrine tumor or other somatostatin receptor positive tumor
    Arm/Group Title Diagnostic (Gallium Ga 68-edotreotide PET/CT)
    Arm/Group Description Patients receive gallium Ga 68-edotreotide IV and undergo PET/CT scan. Within 120 days, patients undergo standard indium In 111 pentetreotide contrast-enhanced CT or MRI scan. Patients may undergo a second gallium Ga 68-edotreotide PET/CT scan within 3-6 months if the lesions of the first scan cannot be confirmed. gallium Ga 68-edotreotide: Given IV positron emission tomography/computed tomography: Undergo gallium Ga 68-edotreotide PET/CT scan indium In 111 pentetreotide: Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan computed tomography: Undergo indium In 111 pentetreotide contrast-enhanced CT scan contrast-enhanced magnetic resonance imaging: Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan
    Measure Participants 34
    Specificity of 68Ga-DOTATOC
    100
    Specificity of Octreoscan
    100
    Specificity of Conventional Imaging (CI)
    47.82

    Adverse Events

    Time Frame Adverse events were collected over 6 months at the following time points: 1) screening visit which occurred within 30 days of Ga-68 DOTATOC PET/CT 2) at scan 1 3) 1-7 days post scan 1 4) at scan 2 5) 1-7 days post scan 2
    Adverse Event Reporting Description
    Arm/Group Title Diagnostic (Gallium Ga 68-edotreotide PET/CT)
    Arm/Group Description Patients receive gallium Ga 68-edotreotide IV and undergo PET/CT scan. Within 120 days, patients undergo standard indium In 111 pentetreotide contrast-enhanced CT or MRI scan. Patients may undergo a second gallium Ga 68-edotreotide PET/CT scan within 3-6 months if the lesions of the first scan cannot be confirmed. gallium Ga 68-edotreotide: Given IV positron emission tomography/computed tomography: Undergo gallium Ga 68-edotreotide PET/CT scan indium In 111 pentetreotide: Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan computed tomography: Undergo indium In 111 pentetreotide contrast-enhanced CT scan contrast-enhanced magnetic resonance imaging: Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan
    All Cause Mortality
    Diagnostic (Gallium Ga 68-edotreotide PET/CT)
    Affected / at Risk (%) # Events
    Total 1/68 (1.5%)
    Serious Adverse Events
    Diagnostic (Gallium Ga 68-edotreotide PET/CT)
    Affected / at Risk (%) # Events
    Total 0/68 (0%)
    Other (Not Including Serious) Adverse Events
    Diagnostic (Gallium Ga 68-edotreotide PET/CT)
    Affected / at Risk (%) # Events
    Total 11/68 (16.2%)
    Gastrointestinal disorders
    Diarrhea 2/68 (2.9%) 2
    Gastrointestinal disorders - Other, specify 1/68 (1.5%) 1
    Nausea 4/68 (5.9%) 4
    General disorders
    General disorders and administration site conditions - Other, specify 1/68 (1.5%) 1
    Pain 2/68 (2.9%) 2
    Musculoskeletal and connective tissue disorders
    Back pain 3/68 (4.4%) 3
    Musculoskeletal and connective tissue disorder - Other, specify 1/68 (1.5%) 1
    Respiratory, thoracic and mediastinal disorders
    Dyspnea 1/68 (1.5%) 1
    Vascular disorders
    Flushing 2/68 (2.9%) 2
    Vascular disorders - Other, specify 1/68 (1.5%) 1

    Limitations/Caveats

    Although 67/68 were eligible and received the 68Ga-DOTATOC PET scan, four patients did not receive the 111In-Octreotide SPECT scan. Of the 63 subjects who received both scans, 30 subjects did not receive the 111In-Octreotide SPECT scan within either the six months prior to or six months after the 68Ga-DOTATOC PET scan. This left only 34 subjects who could be fully evaluated for comparison of number of lesions found on both scans.

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title M. Sue O'Dorisio, MD, PhD
    Organization University of Iowa
    Phone 319-335-7234
    Email sue-odorisio@uiowa.edu
    Responsible Party:
    Sue O'Dorisio, Principal Investigator, University of Iowa
    ClinicalTrials.gov Identifier:
    NCT01869725
    Other Study ID Numbers:
    • 201212736
    • NCI-2013-00936
    • P30CA086862
    • R01CA167632
    First Posted:
    Jun 5, 2013
    Last Update Posted:
    Sep 22, 2021
    Last Verified:
    Dec 1, 2018