Investigation of 68Ga-DOTATATE, as a PET Imaging Agent in Neuroendocrine Tumor Patients

• Status: Completed
• Trial end date: 2017-06-16
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jonsson Comprehensive Cancer Center

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.