NCT00335751

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 12, 2006

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

July 31, 2020

Status Verified

January 1, 2016

Enrollment Period

2.5 years

First QC Date

June 8, 2006

Last Update Submit

July 29, 2020

Conditions

Sarcoma

Keywords

recurrent adult soft tissue sarcomastage I adult soft tissue sarcomalocalized osteosarcomametastatic osteosarcomarecurrent osteosarcomastage II adult soft tissue sarcomastage III adult soft tissue sarcomastage IV adult soft tissue sarcoma

Outcome Measures

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.

    6 months

Secondary Outcomes (4)

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

    6 months

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

    6 months

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

    6 months

  • •Correlate changes in glucose metabolic activity early and late after treatment with degree of tumor necrosis at the time of surgery.

    6 months

Study Arms (1)

positron emission tomography computed tomography (PET/CT)

EXPERIMENTAL

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.

Procedure: positron emission tomography computed tomography (PET/CT)

Interventions

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.

positron emission tomography computed tomography (PET/CT)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

Location

MeSH Terms

Conditions

SarcomaOsteosarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Bone TissueNeoplasms, Connective Tissue

Study Officials

  • Johannes Czernin, MD

    Jonsson Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2006

First Posted

June 12, 2006

Study Start

January 1, 2006

Primary Completion

July 1, 2008

Study Completion

October 1, 2011

Last Updated

July 31, 2020

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)