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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00335751
First received: June 8, 2006
Last updated: July 27, 2012
Last verified: July 2012
History of Changes
  Purpose

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 Intervention
Sarcoma
 Procedure: computed tomography
Procedure: positron emission tomography
Procedure: radionuclide imaging
Radiation: fludeoxyglucose F 18

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Glucose Metabolic Response by PET/CT to Sarcoma Treatments

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Jonsson Comprehensive Cancer Center:

Primary Outcome Measures:
  • correlating progression-free survival, overall survival, and degree of tumor necrosis at the time of surgery with Glucose metabolic activity, early and late after treatment. [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: January 2006
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00335751

Locations
United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Johannes Czernin, MD Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00335751     History of Changes
Other Study ID Numbers: CDR0000480348, P30CA016042, UCLA-0508095-01
Study First Received: June 8, 2006
Last Updated: July 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Jonsson Comprehensive Cancer Center:
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

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on October 16, 2012