68Ga DOTA-TATE PET/CT in Somatostatin Receptor Positive Tumors

Carcinoid Tumors Clinical Trial

Official title:

68Ga DOTA-TATE PET/CT in the Evaluation of Patients With Somatostatin Receptor Positive Tumors

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT01980732
• Other study ID #: NET0017
• Secondary ID: 26988
• Status: No longer available
• Phase: N/A
• First received: November 4, 2013
• Last updated: August 21, 2017

Study information

• Verified date: August 2017
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Carcinoid Tumor
• Carcinoid Tumors
• Islet Cell (Pancreatic NET)
• Neoplasms
• Neuroendocrine Tumors
• Other Neuroendocrine Tumors

Intervention

Drug:
• 68Ga-DOTA TATE
Patients with somatostatin receptor positive tumors will be evaluated with 68Ga-DOTA TATE PET/CT in addition to conventional imaging.

Locations

Country	Name	City	State
United States	Stanford University, School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Andrei Iagaru

Country where clinical trial is conducted

United States,