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

Sponsor

Jonsson Comprehensive Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00335751

Collaborator

(none)

120

Enrollment

Location

Arm

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sarcoma	Procedure: positron emission tomography computed tomography (PET/CT)	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Glucose Metabolic Response by PET/CT to Sarcoma Treatments

Study Start Date :

Jan 1, 2006

Actual Primary Completion Date :

Jul 1, 2008

Actual Study Completion Date :

Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Procedure: 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.

Arm

Intervention/Treatment

Experimental: 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.

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

Outcome Measures

Primary Outcome Measures

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

•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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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