Sarcoma
Conditions
Keywords
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
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.
Interventions
PROCEDUREpositron 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.
Sponsors
Jonsson Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| •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 |
Countries
United States
Outcome results
None listed