68Ga DOTA-TATE PET/CT in Somatostatin Receptor Positive Tumors
Expanded access is currently available for this treatment.
Verified July 2014 by Stanford University
Information provided by (Responsible Party):
Andrei Iagaru, Stanford University
First received: November 4, 2013
Last updated: July 22, 2014
Last verified: July 2014
The primary objective of the study is to evaluate 68Ga-DOTA TATE PET/CT for staging and monitoring response to chemotherapy in patients with carcinoid, neuroendocrine tumors, medullary thyroid cancer and other cancers expressing somatostatin receptors.
Islet Cell (Pancreatic NET)
Other Neuroendocrine Tumors
Drug: 68Ga-DOTA TATE
What is Expanded Access?
||68Ga DOTA-TATE PET/CT in the Evaluation of Patients With Somatostatin Receptor Positive Tumors
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||November 2018 (Final data collection date for primary outcome measure)
Drug: 68Ga-DOTA TATE
Patients with somatostatin receptor positive tumors will be evaluated with 68Ga-DOTA TATE PET/CT in addition to conventional imaging.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Greater than 18 years-old at the time of radiotracer administration
- Provides written informed consent
- Known diagnosis of NET or suspected SSTR positive tumors by 111In-Octreotide scan, 18FDG-PET, or MRI of the abdomen when clinically indicated
- Karnofsky score greater than 50 or ECOG Performance Status 0-2
- Women of childbearing age must have a negative pregnancy test at screening/baseline
- Able to remain still for duration of each imaging procedure (about one hour)
- Less than 18 years-old at the time of radiotracer administration
- Pregnant or nursing
- Serum creatinine >3.0 mg/dL
- Hepatic enzyme levels more than 5 times upper limit of normal.
- Use of any other investigational product or device within 30 days prior to dosing, or known requirement for any other investigational agent prior to completion of all scheduled study assessments.
- Inability to lie still for the entire imaging time
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01980732
|Stanford University Cancer Institute
|Stanford, California, United States, 94305 |
|Contact: Elizabeth Chitouras 650-498-0623 firstname.lastname@example.org |
|Principal Investigator: Andrei Iagaru |
No publications provided
||Andrei Iagaru, Assistant Professor of Radiology - Nuclear Medicine, Stanford University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 4, 2013
||July 22, 2014
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 24, 2014
Neoplasms, Germ Cell and Embryonal
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