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Glucose Metabolic Response by PET/CT to Sarcoma Treatments


N/A
18 Years
N/A
Not Enrolling
Both
Sarcoma

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Trial Information

Glucose Metabolic Response by PET/CT to Sarcoma Treatments


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.


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

correlating progression-free survival, overall survival, and degree of tumor necrosis at the time of surgery with Glucose metabolic activity, early and late after treatment.

Safety Issue:

No

Principal Investigator

Johannes Czernin, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

CDR0000480348

NCT ID:

NCT00335751

Start Date:

January 2006

Completion Date:

October 2011

Related Keywords:

  • Sarcoma
  • 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
  • Sarcoma

Name

Location

Jonsson Comprehensive Cancer Center at UCLALos Angeles, California  90095-1781