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

Sarcoma Clinical Trial

Official title:

Glucose Metabolic Response by PET/CT to Sarcoma Treatments

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00335751
• Other study ID #: CDR0000480348
• Secondary ID: UCLA-0508095-01
• Status: Completed
• Phase: N/A
• Start date: January 2006
• Est. completion date: October 2011

Study information

• Verified date: January 2016
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 2011
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcoma

Intervention

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.

Locations

Country	Name	City	State
United States	Jonsson Comprehensive Cancer Center at UCLA	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	•Determine whether FDG-PET/CT scanning is effective in evaluating the response of sarcoma to treatment.		6 months
Secondary	•Determine whether the new FDG-PET/CT device improves the ability to evaluate treatment response early and accurately.		6 months
Secondary	•Correlate changes in glucose metabolic activity early and late after treatment with overall and progression-free survival.		6 months
Secondary	•Correlate changes in glucose metabolic activity early and late after treatment with degree of tumor necrosis at the time of surgery.		6 months