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

July 29, 2020 updated by: Jonsson Comprehensive Cancer Center

Glucose Metabolic Response by PET/CT to Sarcoma Treatments

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095-1781
        • Jonsson Comprehensive Cancer Center at UCLA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 6 months
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jonsson Comprehensive Cancer Center

Investigators

  • Study Chair: Johannes Czernin, MD, Jonsson Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

June 8, 2006

First Submitted That Met QC Criteria

June 8, 2006

First Posted (Estimate)

June 12, 2006

Study Record Updates

Last Update Posted (Actual)

July 31, 2020

Last Update Submitted That Met QC Criteria

July 29, 2020

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000480348
  • UCLA-0508095-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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