|Phase II, Phase I||Diagnostic||Closed||18 and over||Other||DOTATATE12-001920|
This is a prospective, Phase 1-2, single center study in a total of 100 subjects with Neuroendocrine Tumors (NETs). Study participants will receive a one-time administration of 68Ga-DOTATATE and undergo a PET/CT imaging study, to investigate its suitability as a PET imaging agent for NETs.
Further Study Information
In this study, we propose to use a well-established PET isotope, 68-Gallium (68Ga), bound to a somatostatin analogue, DOTA-octreotate, or DOTATATE, which has high affinity for the somatostatin receptor type 2 (SSTR2). Most gastro-entero-pancreatic (GEP) NETs express SSTR2 on their cell surfaces; when the radiolabeled SSTR2 analogue binds to these receptors, the radioactive molecule is internalized and transported to the tumor cell nucleus, thus concentrating the radioactivity and improving the signal-to-noise ratio on the PET scan, particularly as the background rapidly clears. This internalization, combined with the improved physical principles of PET imaging, shorter half-life of the 68Ga (68 minutes vs. about three days for 111In), improved radiation dosimetry, faster scanning, and lower cost results in a greatly improved scan for diagnosis, staging and restaging of NET disease compared to conventional 111In-octreotide imaging. Additionally, 68Ga-DOTATATE PET/CT scanning can be performed in 1.5 hours from injection of the radiopharmaceutical to completion of the scan, vs. 2-3 days for 111In-octreotide imaging.
- Known diagnosis of NET, suspected SSTR positive tumors or suspected NET recurrence.
- At least 18 years of age.
- Patient or patient's legally acceptable representative cognitively provides written informed consent.
- Able to provide informed consent.
- Females of childbearing potential must have a negative pregnancy test at screening/baseline.
- 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.
- Patients with a body weight of 400 pounds or more or not able to enter the bore of the PET/CT scanner due to BMI, because of the compromise in image quality with CT, PET/CT and MRI that will result.
- 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.)
- Recognized concurrent active infection.
- Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance.
Trial Lead Organizations/Sponsors
Jonsson Comprehensive Cancer Center at UCLA
|Johannes Czernin||Principal Investigator|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01873248
ClinicalTrials.gov processed this data on April 14, 2014
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