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FDG Tumor Heterogeneity During Chemoradiation as a Predictor of Response in Patients With Cervical Cancer

NCT02317302 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2020-06-11

No results posted yet for this study

Summary

In this study, 50 evaluable patients will undergo one FDG-PET study during their chemoradiation, in addition to the standard of care pretreatment and 3-month post-treatment clinical FDG-PET/CT or FDG-PET/MR scans. From all FDG-PET studies, tumor volume, SUVmax, FDGhetero, and texture maps will be obtained. Evaluating the changes in tumor SUVmax and heterogeneity during treatment will aid in better understanding the role of these biological parameters in inadequate response to chemoradiation. Other researchers, using MRI imaging, have evaluated changes in the cervical tumor volume during treatment. The investigators expect there will be variation in how cervical tumors shrink and change during chemoradiation and therefore we are going to use multiple measures in addition to tumor volume to evaluate cervical tumor metabolic heterogeneity. Being able to predict at diagnosis the patients who are at higher risk for persistent disease following chemoradiation would allow for future studies where these high risk patients could be specifically targeted with more aggressive therapy.

Conditions

Interventions

DEVICE

FDG-PET/MR

DEVICE

FDG-PET/CT

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Perry Grigsby, M.D. · Washington University School of Medicine

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-28
Primary Completion
2020-06-02
Completion
2020-06-02
FDA Device
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 NCT02317302 on ClinicalTrials.gov