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)
• Enrollment: 68
• Location: 1
• Arm: 1
• Actual Duration (Months): 68.8
• Patients Per Site Per Month: 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
Adult Medulloblastoma; Childhood Medulloblastoma; Neuroblastoma; Neuroendocrine Tumor; Somatostatinoma	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)

• Study Protocol and Statistical Analysis Plan - Mar 26, 2015
• Informed Consent Form - Feb 20, 2015

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: Neuroendocrine Tumor; Ga-DOTATOC PET; Imaging
• Additional relevant MeSH terms: Neuroblastoma; Neuroendocrine Tumors; Medulloblastoma; Somatostatinoma; Octreotide; Edotreotide; Indium-111-octreotide; Somatostatin

Study Results

Participant Flow

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
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.