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

Sponsors and Collaborators:	Jonsson Comprehensive Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00335751

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	Drug: fludeoxyglucose F 18 Procedure: computed tomography Procedure: positron emission tomography Procedure: radionuclide imaging

MedlinePlus related topics: Bone Cancer CT Scans Cancer Nuclear Scans Soft Tissue Sarcoma

Drug Information available for: Dextrose Fluorodeoxyglucose F18

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic
Official Title:	Glucose Metabolic Response by PET/CT to Sarcoma Treatments

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

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

Estimated Enrollment:	120
Study Start Date:	January 2006

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

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed bone or soft tissue sarcoma
Scheduled to undergo treatment (i.e., chemotherapy and/or radiotherapy) for sarcoma

PATIENT CHARACTERISTICS:

Not pregnant
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
No 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

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

Contacts and Locations

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

Locations

United States, California
Jonsson Comprehensive Cancer Center at UCLA	Recruiting
Los Angeles, California, United States, 90095-1781
Contact: Clinical Trials Office - Jonsson Comprehensive Cancer Center a 888-798-0719

Sponsors and Collaborators

Jonsson Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Johannes Czernin, MD

Jonsson Comprehensive Cancer Center

More Information

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

Study ID Numbers:	CDR0000480348, UCLA-0508095-01
Study First Received:	June 8, 2006
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00335751
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Neoplasms, Connective and Soft Tissue
Bone Neoplasms
Malignant mesenchymal tumor
Bone neoplasms
Sarcoma

Osteosarcoma
Osteogenic sarcoma
Soft tissue sarcomas
Recurrence

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009