Glucose Metabolic Response by PET/CT to Sarcoma Treatments
18 Years
N/A
Both
Sarcoma
Trial Information
Glucose Metabolic Response by PET/CT to Sarcoma Treatments
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.
Inclusion Criteria:
- Histologically or cytologically confirmed bone or soft tissue sarcoma
- Scheduled to undergo treatment (i.e., chemotherapy and/or radiotherapy) for sarcoma
- Negative pregnancy test
- Fertile patients must use effective contraception
- Not claustrophobic
- Able to lie supine for 1 hour
- Patients with diabetes mellitus allowed provided serum glucose levels ≤ 200 mg/dL
Exclusion Criteria:
- pregnant
- other malignancies within the past 5 years (except completely resected cervical or
nonmelanoma skin cancer) unless the malignancy was curatively treated and is at low
risk for recurrence
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
correlating progression-free survival, overall survival, and degree of tumor necrosis at the time of surgery with Glucose metabolic activity, early and late after treatment.
Safety Issue:
No
Principal Investigator
Johannes Czernin, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Jonsson Comprehensive Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
CDR0000480348
NCT ID:
NCT00335751
Start Date:
January 2006
Completion Date:
October 2011
Related Keywords:
- Sarcoma
- recurrent adult soft tissue sarcoma
- stage I adult soft tissue sarcoma
- localized osteosarcoma
- metastatic osteosarcoma
- recurrent osteosarcoma
- stage II adult soft tissue sarcoma
- stage III adult soft tissue sarcoma
- stage IV adult soft tissue sarcoma
- Sarcoma
Name | Location |
|---|---|
| Jonsson Comprehensive Cancer Center at UCLA | Los Angeles, California 90095-1781 |
