Phase 2
N=68
Comparative Study of Sensitivity of Ga-DOTATOC PET vs Octreoscan SPECT + CT
Adult Medulloblastoma · Childhood Medulloblastoma · Neuroblastoma · Neuroendocrine Tumor · Somatostatinoma
Bottom Line
View on ClinicalTrials.gov: NCT01869725 ↗Enrolled (actual)
68
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: Comparison of Conventional Imaging and Gallium Ga 68-edotreotide PET Using Concordance in Tumor Detection With Pathology — 28; 0; 1; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- gallium Ga 68-edotreotide (Drug); positron emission tomography/computed tomography (Procedure); indium In 111 pentetreotide (Radiation); computed tomography (Procedure); contrast-enhanced magnetic resonance imaging (Procedure)
- Age
- Pediatric, Adult, Older Adult · 2+ yrs
- Sex
- All
- Sponsor
- Sue O'Dorisio
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of Conventional Imaging and Gallium Ga 68-edotreotide PET Using Concordance in Tumor Detection With Pathology |
28; 0; 1; 5; 23; 0 | — |
| PRIMARY Compare Sensitivity of 68Ga-DOTATOC PET/CT With Octreoscan |
96.55; 79.31; 82.24 | — |
| PRIMARY Compare Specificity of 68Ga-DOTATOC PET/CT With Octreoscan |
100; 100; 47.82 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01869725). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.