CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 97 enrolled
Drug / intervention
68Ga-DOTATATE PET scanradiation
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01396382
NCT01396382Phase 2Completed
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Use of 68Ga-DOTATATE PET Scanning for Diagnosis and Treatment of Metastatic Neuroendocrine Tumors

Vanderbilt-Ingram Cancer Center·interventional·Posted Jul 18, 2011·Updated Mar 29, 2016

In Brief

A Phase 2 clinical trial evaluating 68Ga-DOTATATE PET scan for Neuroendocrine Carcinoma. Completed, enrolled 97 participants across 1 site.

Detailed Summary

Neuroendocrine cancer is an unusual disease and often goes undetected by routine imaging. The 68Ga-DOTATATE PET scan is a new generation of scans that might have improved sensitivity and resolution specifically for neuroendocrine tumors. The investigators will scan people with this cancer and compare it to other conventional imaging methods to see if it improves patient care.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeuroendocrine Carcinoma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 18, 2011
Enrollment StartMar 1, 2010
Primary CompletionMay 1, 2014
Study CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 15.0 years ago

Interventions

68Ga-DOTATATE PET scanradiation

68Ga-DOTATATE will be given in tracer doses and injected intravenously to image tumors by Positron Emission Tomography (PET). Efficacy of the 68Ga-DOTATATE PET scan was assessed and compared to 111In-Pentetreotide scan and to scans with CT and/or MRI. Safety and toxicity were also assessed with pre-injection and post-imaging vital signs, pulse oximetry on room air, 12 lead ECGs, and blood laboratory tests, including tumor markers, liver and renal functions and blood counts, and direct patient questioning. Late delayed tumor markers, liver and renal functions and blood counts were assessed when available.