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

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

Status
NO_LONGER_AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT01980732
Enrollment
Unknown
Registered
2013-11-11
Start date
Unknown
Completion date
Unknown
Last updated
2017-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoid Tumors, Islet Cell (Pancreatic NET), Other Neuroendocrine Tumors

Brief 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.

Interventions

DRUG68Ga-DOTA TATE

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

Sponsors

Andrei Iagaru
Lead SponsorOTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026