PET Scan Combined With CT Scan in Evaluating Treatment Response in Patients Undergoing Treatment for Bone Cancer or Soft Tissue Sarcoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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Glucose Metabolic Response by PET/CT to Sarcoma Treatments

Conditions
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Sarcoma

Intervention / Treatment
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* Procedure: positron emission tomography computed tomography (PET/CT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: positron emission tomography computed tomography (PET/CT)<br>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. | Procedure: positron emission tomography computed tomography (PET/CT)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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