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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

Primary Purpose

Sarcoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
positron emission tomography computed tomography (PET/CT)
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sarcoma focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Jonsson Comprehensive Cancer Center at UCLA

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

positron emission tomography computed tomography (PET/CT)

Arm Description

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.

Outcomes

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.

Secondary Outcome Measures

•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.

Full Information

First Posted
June 8, 2006
Last Updated
July 29, 2020
Sponsor
Jonsson Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00335751
Brief Title
PET Scan Combined With CT Scan in Evaluating Treatment Response in Patients Undergoing Treatment for Bone Cancer or Soft Tissue Sarcoma
Official Title
Glucose Metabolic Response by PET/CT to Sarcoma Treatments
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma
Keywords
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
positron emission tomography computed tomography (PET/CT)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
positron emission tomography computed tomography (PET/CT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
•Determine whether FDG-PET/CT scanning is effective in evaluating the response of sarcoma to treatment.
Time Frame
6 months
Title
•Determine whether the new FDG-PET/CT device improves the ability to evaluate treatment response early and accurately.
Time Frame
6 months
Title
•Correlate changes in glucose metabolic activity early and late after treatment with overall and progression-free survival.
Time Frame
6 months
Title
•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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johannes Czernin, MD
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Jonsson Comprehensive Cancer Center at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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