Last updated: August 26, 2021
Sponsor: Sue O'Dorisio
Overall Status: Completed
Phase
2
Condition
Brain Cancer
Neuroendocrine Carcinoma
Gliomas
Treatment
N/AClinical Study ID
NCT01869725
201212736
R01CA167632
NCI-2013-00936
P30CA086862
Ages > 2 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Signed informed consent
- Biopsy proven neuroendocrine tumor, neuroblastoma, medulloblastoma, or othersomatostatin receptor positive tumor
- Off Sandostatin (octreotide acetate)-long acting release (LAR) > 4 weeks and offimmediate release (subcutaneous) for 12 hrs prior to 68Ga-DOTATOC PET-CT
- Karnofsky performance status or Lansky Play Scale status of >= 50 (or EasternCooperative Oncology Group [ECOG]/World Health Organization [WHO] equivalent)
- Subject is male; or is a female who is either pre-menarchal, surgically sterile (hashad a documented bilateral oophorectomy and/or documented hysterectomy),postmenopausal (> 1 years without menses), non-lactating, or of childbearing potentialfor whom a serum pregnancy test (with the results known prior to investigationalproduct administration) is negative; a negative serum pregnancy test will be requiredfor all female subjects with child bearing potential; if a false pregnancy test issuspected, e.g., perimenopausal condition, an obstetrician will be consulted todetermine 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 ormetastases available for ribonucleic acid (RNA) and immunohistochemistry (IHC)
Exclusion
Exclusion Criteria:
- Pregnancy or breast feeding
- Surgical resection, chemotherapy, radiation therapy, or biologic therapy since lastOctreoscan + CT; continuation of the same dose of Sandostatin-LAR or subcutaneousSandostatin 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 ableto 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 imagingexaminations due to other reasons (severe claustrophobia, radiation phobia, etc.)
- Any additional medical condition, serious intercurrent illness, or other extenuatingcircumstance that, in the opinion of the investigator, may significantly interferewith study compliance
Study Design
Total Participants: 68
Study Start date:
April 01, 2013
Estimated Completion Date:
December 26, 2018
Study Description
Connect with a study center
University of Iowa Hospitals and Clinics
Iowa City, Iowa 52242
United StatesSite Not Available

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