MedTrace Logo

Response Monitoring Trial in Patients With Suspected Recurrence of Glioblastoma

NCT02176720 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2018-08-17

No results posted yet for this study

Summary

It was previously shown that \[18F\]Fluorodopa (FDOPA) PET imaging results in intended management changes in 41% of brain tumor patients. However, its impact on patient outcome defined as survival, costs, and/or quality of life has not been demonstrated. Regulatory agencies require randomized trials to determine the impact of PET on patient management and outcome. In this study we hypothesize that the addition of FDOPA PET will improve patient outcome by more accurately identifying presence or absence of tumor recurrence than conventional imaging.

Conditions

Interventions

DRUG

FDOPA PET

\[18F\]FDOPA radiopharmaceutical will be intravenousely injected for PET-CT scanning of the brain.

Sponsors & Collaborators

Principal Investigators

  • Daniel Lee, MD, PhD · The Methodist Hospital Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2016-03-31
Completion
2016-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT02176720 on ClinicalTrials.gov