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Completed

NCT Number: NCT00335751

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

positron emission tomography computed tomography (PET/CT)

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.

Primary outcomes

  1. 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 outcomes

  1. •Determine whether FDG-PET/CT scanning is effective in evaluating the response of sarcoma to treatment.

    Time frame: 6 months

  2. •Determine whether the new FDG-PET/CT device improves the ability to evaluate treatment response early and accurately.

    Time frame: 6 months

  3. •Correlate changes in glucose metabolic activity early and late after treatment with overall and progression-free survival.

    Time frame: 6 months

  4. •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

Sponsors and collaborators

Lead sponsor

Jonsson Comprehensive Cancer Center

Other

Registry information

Official study title

Glucose Metabolic Response by PET/CT to Sarcoma Treatments

Important dates

Study start
2006
Primary completion
2008
Study completion
2011
First posted
Jun 12, 2006
Registry last updated
Jul 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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