PET Scan Combined With CT Scan in Evaluating Treatment Response in Patients Undergoing Treatment for Bone Cancer or Soft Tissue Sarcoma
- Conditions
- Sarcoma
- Interventions
- Procedure: positron emission tomography computed tomography (PET/CT)
- Registration Number
- NCT00335751
- Lead Sponsor
- Jonsson Comprehensive Cancer Center
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description positron emission tomography computed tomography (PET/CT) positron emission tomography computed tomography (PET/CT) The first PET/CT scan will be performed as part of clinical evaluation of sarcoma; The second PET/CT scan will be performed 6 weeks after the start of chemotherapy treatment OR 6 weeks after the end of radiation therapy, to monitor response of sarcoma to treatment.
- Primary Outcome Measures
Name Time Method Determine whether device that combines fludeoxyglucose ^18F positron-emission tomography (FDG-PET) and CT scanning (FDG-PET/CT) can accurately locate and determine disease in patients who are undergoing treatment for bone or soft tissue sarcoma. 6 months
- Secondary Outcome Measures
Name Time Method •Determine whether FDG-PET/CT scanning is effective in evaluating the response of sarcoma to treatment. 6 months •Determine whether the new FDG-PET/CT device improves the ability to evaluate treatment response early and accurately. 6 months •Correlate changes in glucose metabolic activity early and late after treatment with overall and progression-free survival. 6 months •Correlate changes in glucose metabolic activity early and late after treatment with degree of tumor necrosis at the time of surgery. 6 months
Trial Locations
- Locations (1)
Jonsson Comprehensive Cancer Center at UCLA
🇺🇸Los Angeles, California, United States