Comparative Study of Sensitivity of Ga-DOTATOC PET vs Octreoscan SPECT + CT
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 |
---|---|---|
|
Phase 2 |
Detailed Description
PRIMARY OBJECTIVES:
- 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
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:
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:
Procedure: computed tomography
Undergo indium In 111 pentetreotide contrast-enhanced CT scan
Other Names:
Procedure: contrast-enhanced magnetic resonance imaging
Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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.
- 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
- 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
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.- 201212736
- NCI-2013-00936
- P30CA086862
- R01CA167632
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
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%
|
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
|
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
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 |
sue-odorisio@uiowa.edu |
- 201212736
- NCI-2013-00936
- P30CA086862
- R01CA167632