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

NCT ID: NCT00335751

Last Updated: 2020-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2011-10-31

Brief Summary

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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

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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.

Conditions

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Sarcoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

positron emission tomography computed tomography (PET/CT)

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Johannes Czernin, MD

Role: STUDY_CHAIR

Jonsson Comprehensive Cancer Center

Locations

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Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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UCLA-0508095-01

Identifier Type: -

Identifier Source: secondary_id

CDR0000480348

Identifier Type: -

Identifier Source: org_study_id

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