Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2026-01-27 @ 4:45 AM
Study NCT ID:
NCT03613259
Status:
WITHDRAWN
Last Update Posted:
2020-06-09
First Post:
2018-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fluorothymidine F-18 PET in Diagnosing Patients With Intermediate or High Grade Soft Tissue Sarcoma
Sponsor:
OHSU Knight Cancer Institute
Organization:
Study Overview
Official Title:
A Pilot Study Investigating ¹⁸F-FLT-PET as a Marker of Response to Preoperative Radiotherapy in Soft Tissue Sarcoma
Status:
WITHDRAWN
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding expired
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This pilot early phase I trial studies how well fluorothymidine F-18 positron emission tomography (PET) works in imaging patients with intermediate or high grade soft tissue sarcoma. Fluorothymidine F-18 PET may provide useful information about the tumor's response to treatment and may give the doctors early results that would better help to plan the post-surgical therapy.
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine fluorothymidine F-18 (¹⁸F-FLT) uptake parameters before and after radiotherapy.
SECONDARY OBJECTIVES:
I. To correlate ¹⁸F-FLT uptake post-radiotherapy scan with pathologic response. II. To correlate levels the mitotic index in surgical specimens with the ¹⁸F-FLT uptake in post-radiation scans.
III. To correlate ¹⁸F-FLT uptake both pre- and post-radiotherapy with magnetic resonance imaging (MRI) enhancement both within and around the tumor.
TERTIARY OBJECTIVES:
I. To compare ¹⁸F-FLT uptake and fludeoxyglucose F-18 (FDG) uptake when FDG-PET-computed tomography (CT) is available, pre-radiation, post-radiation, or both.
II. To compare ¹⁸F-FLT uptake in post-radiation scans with local recurrences looking for spatial correlation.
OUTLINE:
Patients receive fluorothymidine F-18 intravenously (IV) over 1 minute and undergo PET scan over 60 minutes 21 or less days prior to standard of care radiation therapy and 14 or less days prior to the standard of care surgery.
After completion of study, patients are followed up for 2 years.
I. To determine fluorothymidine F-18 (¹⁸F-FLT) uptake parameters before and after radiotherapy.
SECONDARY OBJECTIVES:
I. To correlate ¹⁸F-FLT uptake post-radiotherapy scan with pathologic response. II. To correlate levels the mitotic index in surgical specimens with the ¹⁸F-FLT uptake in post-radiation scans.
III. To correlate ¹⁸F-FLT uptake both pre- and post-radiotherapy with magnetic resonance imaging (MRI) enhancement both within and around the tumor.
TERTIARY OBJECTIVES:
I. To compare ¹⁸F-FLT uptake and fludeoxyglucose F-18 (FDG) uptake when FDG-PET-computed tomography (CT) is available, pre-radiation, post-radiation, or both.
II. To compare ¹⁸F-FLT uptake in post-radiation scans with local recurrences looking for spatial correlation.
OUTLINE:
Patients receive fluorothymidine F-18 intravenously (IV) over 1 minute and undergo PET scan over 60 minutes 21 or less days prior to standard of care radiation therapy and 14 or less days prior to the standard of care surgery.
After completion of study, patients are followed up for 2 years.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
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-2017-00833 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| SOL-16169-LX | None | None | View | |
| STUDY00016373 | OTHER | OHSU Knight Cancer Institute | View | |
| P01CA042045 | NIH | None | https://reporter.nih.gov/quic… | View |
| P30CA069533 | NIH | None | https://reporter.nih.gov/quic… | View |