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

Jonsson Comprehensive Cancer Center

Status: Completed

Conditions: Sarcoma

Treatments: Procedure: positron emission tomography computed tomography (PET/CT)

Study type: Interventional

Funder types: Other

Identifiers

NCT00335751

CDR0000480348

UCLA-0508095-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

positron emission tomography computed tomography (PET/CT)

Experimental group

Description:

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.

Treatment:

Procedure: positron emission tomography computed tomography (PET/CT)