Participants in this study have been diagnosed with a tumor such as a carcinoid, neuroendocrine tumor, neuroblastoma, Ewing's sarcoma, or brain tumor that has cells which carry somatostatin receptors. The purpose of this research study is to see if the tumor can be identified using a special procedure called a positron emission tomography (PET) scan and how the results of this imaging procedure will change the management of the tumor.
Completed
Phase 2
| Drug | Synonyms | Arms |
|---|---|---|
| 68Ga-DOTATOC PET/CT | 68Ga-DOTATOC PET/CT |
This is a prospective, Phase II, single center, open-label study in a total of 200
participants with histologically proven neuroendocrine tumor or other somatostatin receptor
positive tumors. Eligible participants will undergo baseline assessments at enrollment. They
will receive 68Ga-DOTATOC and undergo a PET/CT imaging study. Participants may receive a
second 68Ga-DOTATOC PET/CT for restaging after therapy 12-36 months following the first scan.
| Name | Type | Description | Interventions |
|---|---|---|---|
| 68Ga-DOTATOC PET/CT | Other | Study participants will receive 68Ga-DOTATOC and undergo a PET/CT imaging study. Subjects may receive a second 68Ga-DOTATOC PET/CT for restaging after therapy 12-36 months following the first scan. |
|
Inclusion Criteria:
1. Signed informed consent
2. Age ≥ 6 months
3. Histologically diagnosed neuroendocrine tumor or other tumor with probable
somatostatin receptors subtype 2
4. Karnofsky performance status or Lansky Play Scale status of ≥ 60 (or ECOG/WHO
equivalent)
5. Subject is male; or is a female who is either surgically sterile (has had a documented
bilateral oophorectomy and/or documented hysterectomy), postmenopausal (> 1 years
without menses), ≥60 years old,or of childbearing potential for whom a pregnancy test
(with the results known prior to investigational product administration) is negative.
A negative 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 not capable of becoming
pregnant. Female must also be non-lactating.
Exclusion Criteria:
1. Subject weighs more than 450 pounds. (Subjects who weigh more than 450 pounds will not
be able to fit inside the imaging machines) or otherwise cannot be safely fit into the
imaging system.
2. Inability to lie still for the entire imaging time (due to cough, severe arthritis,
etc.)
3. Inability to complete the needed investigational and standard-of-care imaging
examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
4. Any additional medical condition, serious intercurrent illness, or other extenuating
circumstance that, in the opinion of the investigator, may significantly interfere
with study compliance.
5. Peptide receptor radionuclide therapy (PRRT) within 4 weeks of Ga-68 DOTATOC PET/CT
scan.
6. Treatment with Sandostatin LAR within 4 weeks, SQ Octreotide within 12 hours, or
Lanreotide injection within 8 weeks of Ga-68 DOTATOC PET/CT (+/-5%).
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 6 Months |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
| Measure: | Number of Participants With a Change in Treatment Management Based on Findings of the Gallium Ga 68-edotreotide PET/CT Scan |
| Time Frame: | 36 months |
| Safety Issue: | |
| Description: | Referring physicians will be asked to fill out pre-PET and post-PET scan forms to provide information on the management and treatment strategy of the patient before the PET-CT scan and after the information from the PET-CT study is available. This is the same methodology used in the National Oncologic PET Registry study; change in management strategy criteria are modified for the specific treatment strategies used in NET. |
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Completed |
| Lead Sponsor: | Sue O'Dorisio |
December 21, 2020
