Clinical trial NCT00335751: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2006-06-12
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: 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.
timeFrame: 6 months
Secondary outcomes:
measure: •Determine whether FDG-PET/CT scanning is effective in evaluating the response of sarcoma to treatment.
timeFrame: 6 months
measure: •Determine whether the new FDG-PET/CT device improves the ability to evaluate treatment response early and accurately.
timeFrame: 6 months
measure: •Correlate changes in glucose metabolic activity early and late after treatment with overall and progression-free survival.
timeFrame: 6 months
measure: •Correlate changes in glucose metabolic activity early and late after treatment with degree of tumor necrosis at the time of surgery.
timeFrame: 6 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Jonsson Comprehensive Cancer Center at UCLA
state: California
Study officials:
affiliation: Jonsson Comprehensive Cancer Center
name: Johannes Czernin, MD
role: STUDY_CHAIR
References: