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[18F]FLT-PET as a Predictive Imaging Biomaker of Treatment Responses to Regorafenib

NCT02175095 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2024-10-04

Study results available
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Summary

Regorafenib is approved in the treatment for metastatic colorectal cancer patients who have been progressed after standard therapies, however, there has not been a predictive biomarker. The investigators designed this study to investigate whether \[18F\]FLT-PET might paly a role as a predictive imaging biomarker of treatment responses to regorafenib.

Conditions

Interventions

DRUG

Regorafenib

Regorafenib will be administered 160 mg/day given orally on day 1 to days 21 following 7 days break, which consists of 4 weeks as 1 cycle. Treatment will be repeated every 4 weeks and continued until disease progression, unacceptable toxicity or the patient's refusal.

DIAGNOSTIC_TEST

[18F]FLT-PET

\[18F\]FLT-PET scans before and on 21st day from the administration of regorafenib.

DIAGNOSTIC_TEST

[18F]FDG-PET

\[18F\]FDG-PET will be performed before treatment and at 21 days after treatment.

Sponsors & Collaborators

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Yong Sang Hong, M.D., Ph.D. · Asan Medical Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-18
Primary Completion
2016-08-10
Completion
2019-04-30

Countries

  • South Korea

Study Locations

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Entities

Drugs
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 NCT02175095 on ClinicalTrials.gov