Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-01-04 @ 4:40 AM
Study NCT ID:
NCT00335751
Status:
COMPLETED
Last Update Posted:
2020-07-31
First Post:
2006-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PET Scan Combined With CT Scan in Evaluating Treatment Response in Patients Undergoing Treatment for Bone Cancer or Soft Tissue Sarcoma
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
Glucose Metabolic Response by PET/CT to Sarcoma Treatments
Status:
COMPLETED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE: Diagnostic procedures, such as PET scan and CT scan, may help doctors determine the extent of cancer and predict a patient's response to treatment and help plan the best treatment.
PURPOSE: This clinical trial is studying how well PET scan combined with CT scan evaluates treatment response in patients undergoing treatment for bone cancer or soft tissue sarcoma.
PURPOSE: This clinical trial is studying how well PET scan combined with CT scan evaluates treatment response in patients undergoing treatment for bone cancer or soft tissue sarcoma.
Detailed Description:
OBJECTIVES:
* Determine whether an FDA-approved device that combines fludeoxyglucose \^18F positron-emission tomography (FDG-PET) and CT scanning (FDG-PET/CT) can accurately locate and determine the extent of disease in patients who are undergoing treatment for bone or soft tissue sarcoma.
* Determine whether FDG-PET/CT scanning is effective in evaluating the response of sarcoma to treatment.
* Determine whether the new FDG-PET/CT device improves the ability to evaluate treatment response early and accurately.
* Correlate changes in glucose metabolic activity early and late after treatment with overall and progression-free survival.
* Correlate changes in glucose metabolic activity early and late after treatment with degree of tumor necrosis at the time of surgery.
OUTLINE: This is a prospective, pilot study. Patients are stratified according to disease (high-grade soft tissue sarcoma vs low-grade soft tissue sarcoma vs osteosarcoma).
Patients undergo fludeoxyglucose \^18F positron-emission tomography (FDG-PET)/CT scanning at baseline and then within 2 weeks and 12 weeks after the start of treatment (total of 3 scans).
PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.
* Determine whether an FDA-approved device that combines fludeoxyglucose \^18F positron-emission tomography (FDG-PET) and CT scanning (FDG-PET/CT) can accurately locate and determine the extent of disease in patients who are undergoing treatment for bone or soft tissue sarcoma.
* Determine whether FDG-PET/CT scanning is effective in evaluating the response of sarcoma to treatment.
* Determine whether the new FDG-PET/CT device improves the ability to evaluate treatment response early and accurately.
* Correlate changes in glucose metabolic activity early and late after treatment with overall and progression-free survival.
* Correlate changes in glucose metabolic activity early and late after treatment with degree of tumor necrosis at the time of surgery.
OUTLINE: This is a prospective, pilot study. Patients are stratified according to disease (high-grade soft tissue sarcoma vs low-grade soft tissue sarcoma vs osteosarcoma).
Patients undergo fludeoxyglucose \^18F positron-emission tomography (FDG-PET)/CT scanning at baseline and then within 2 weeks and 12 weeks after the start of treatment (total of 3 scans).
PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|---|
| UCLA-0508095-01 | None | None | View |