Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2026-03-01 @ 6:10 AM
Study NCT ID:
NCT03611205
Status:
WITHDRAWN
Last Update Posted:
2019-08-07
First Post:
2018-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interim Digital PET/CT in Predicting Outcomes for Participants With Locally Advanced Oropharyngeal Cancer Undergoing Chemoradiation Therapy
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
A Pilot Study to Evaluate the Utility of Interim Digital PET/CT in Predicting Outcomes for Locally Advanced Oropharyngeal Cancer
Status:
WITHDRAWN
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This pilot trial studies how well interim digital positron emission tomography (PET)/computed tomography (CT) works in predicting outcomes in participants with oropharyngeal cancer that has spread from its original site of growth to nearby tissues or lymph nodes who are undergoing chemoradiation therapy. Diagnostic procedures, such as PET/CT may help measure a participant's response to treatment.
Detailed Description:
PRIMARY OBJECTIVES:
I. To evaluate the utility of early (i.e. during treatment) digital (d)PET as a diagnostic tool to predict local control 6 months after definitive chemoradiation for patients with locally advanced oropharyngeal carcinoma.
SECONDARY OBJECTIVES:
I. To study the association between dynamic dPET parameters taken at early time points (i.e. during treatment) and complete response (CR) on PET after definitive chemoradiation.
II. To study the association between dynamic dPET parameters taken at early time points (i.e. during) treatment and 2 year LC after definitive chemoradiation.
III. To assess the ability of dynamic dPET compared to conventional PET or conventional-equivalent dPET reconstruction to identify tumor volumes with greater sensitivity at the time of before (dPET1), during (dPET2, dPET3) and after (dPET4, dPET5) chemoradiation.
OUTLINE:
Participants receive radiotracer injection and undergo dPET/CT over 20-75 minutes at baseline, during the 2nd and 4th week of radiotherapy, and 3 months after the completion of chemoradiation therapy.
I. To evaluate the utility of early (i.e. during treatment) digital (d)PET as a diagnostic tool to predict local control 6 months after definitive chemoradiation for patients with locally advanced oropharyngeal carcinoma.
SECONDARY OBJECTIVES:
I. To study the association between dynamic dPET parameters taken at early time points (i.e. during treatment) and complete response (CR) on PET after definitive chemoradiation.
II. To study the association between dynamic dPET parameters taken at early time points (i.e. during) treatment and 2 year LC after definitive chemoradiation.
III. To assess the ability of dynamic dPET compared to conventional PET or conventional-equivalent dPET reconstruction to identify tumor volumes with greater sensitivity at the time of before (dPET1), during (dPET2, dPET3) and after (dPET4, dPET5) chemoradiation.
OUTLINE:
Participants receive radiotracer injection and undergo dPET/CT over 20-75 minutes at baseline, during the 2nd and 4th week of radiotherapy, and 3 months after the completion of chemoradiation therapy.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2018-01322 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| P30CA016058 | NIH | None | https://reporter.nih.gov/quic… | View |