MedTrace Logo

Safety of 68Ga-DOTA-tyr3-Octreotide PET in Diagnosis of Solid Tumors

NCT01619865 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 223

Last updated 2021-07-27

Study results available
· View outcomes & findings →

Summary

This protocol is designed to test the efficacy of 68Ga-DOTATOC PET/CT in diagnosis, staging, and measurement of response to treatment in patients with somatostatin receptor positive tumors. Goals are to 1) compare this unique PET/CT scan with the current standard of care which is a combination of Octreoscan SPECT (single photon emission tomography) plus a high resolution, contrast enhanced CT; 2) Determine the sensitivity of 68Ga-DOTATOC PET/CT in diagnosis of patients with suspected somatostatin receptor positive tumor; and 3) For those patients who have had recent treatment (e.g., surgery, chemotherapy, targeted therapy such as anti-angiogenics, kinase inhibitors, peptide receptor radiotherapy), this scan will be used to measure response to treatment. These studies will be obtained with the long term goal of submitting a New Drug Application (NDA) for FDA approval of 68Ga-DOTATOC PET/CT in adults and children.

Conditions

Interventions

DRUG

68Ga-DOTATOC PET/CT

1 -5 mCi 68Ga-DOTATOC (10-50 ugm DOTATOC)administered once via IV.

Sponsors & Collaborators

  • Sue O'Dorisio

    lead OTHER

Principal Investigators

  • Sue O'Dorisio, MD · University of Iowa

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-21
Primary Completion
2017-08-27
Completion
2017-08-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01619865 on ClinicalTrials.gov