Status:
COMPLETED
Comparative Study of Sensitivity of Ga-DOTATOC PET vs Octreoscan SPECT + CT
Lead Sponsor:
Sue O'Dorisio
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Adult Medulloblastoma
Childhood Medulloblastoma
Eligibility:
All Genders
2+ years
Phase:
PHASE2
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 diagno...
Detailed Description
PRIMARY OBJECTIVES: I. 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 26 2018
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT01869725
Start Date
April 1 2013
End Date
December 26 2018
Last Update
September 22 2021
Active Locations (1)
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1
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242