PET and/or MRI Scans in Assessing Tumor Response in Patients Receiving Antiangiogenesis Therapy

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00019565
First received: July 11, 2001
Last updated: April 23, 2012
Last verified: September 2007
  Purpose

RATIONALE: Diagnostic procedures, such as PET and MRI scans, may help to measure a patient's response to treatment.

PURPOSE: This diagnostic trial is studying how well PET and/or MRI scans work in assessing changes in tumor blood supply in patients receiving antiangiogenesis therapy.


Condition Intervention
Unspecified Adult Solid Tumor, Protocol Specific
Procedure: magnetic resonance imaging
Procedure: positron emission tomography
Radiation: fludeoxyglucose F 18

Study Type: Interventional
Study Design: Primary Purpose: Diagnostic
Official Title: The Use of Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI) to Assess the Effects of Anti-neoplastic Therapy on Tumor Associated Vasculature

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 145
Study Start Date: October 1998
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Evaluate the ability of positron emission tomography (PET) to assess the effect of therapy directed against tumor vasculatures on tumor blood flow and tumor blood volume in patients enrolled on a treatment protocol evaluating a therapeutic modality effecting the tumor associated vasculature.
  • Evaluate the ability of PET to assess the effects of this type of therapy regimen on tumor uptake of fluorodeoxyglucose in these patients.
  • Evaluate the ability of magnetic resonance imaging (MRI) to assess the effects of therapy directed against the tumor vasculature on tumor blood flow and tumor vascular density in these patients.
  • Compare the findings on PET and/or MRI with those obtained from conventional CT in this patient population.

OUTLINE: This is a diagnostic study conducted concurrently with a therapeutic modality study.

Patients have magnetic resonance imaging and/or positron emission tomography (PET) scans performed prior to start of therapy, 6 weeks and 16 weeks following the initiation of therapy, and 6 weeks following the completion of therapy. Each scan requires about 1-3 hours. Patients receive up to 3 different PET scans including tumor blood flow scan with H2015, tumor blood volume scan with 11CO, and glucose uptake scan with fludeoxyglucose F 18.

PROJECTED ACCRUAL: A total of 145 patients will be accrued for this study within 2 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Eligible for a treatment protocol evaluating a therapeutic modality that may have an effect on tumor associated vasculature
  • Measurable or evaluable disease by standard CT or MRI
  • At least 1 lesion measuring greater than 2 cm in diameter

PATIENT CHARACTERISTICS:

Age:

  • Over 18

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Creatinine no greater than 2.0 mg/dL

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • No pacemakers, aneurysm clips, shrapnel injury, or implantable electronic devices
  • Weight no greater than 136 kilograms
  • No sensitivity to contrast agents that cannot be controlled with premedication

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00019565

Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
Investigators
Study Chair: Steven K. Libutti, MD NCI - Surgery Branch
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00019565     History of Changes
Obsolete Identifiers: NCT00001709
Other Study ID Numbers: 980163, 98-C-0163, CDR0000066720
Study First Received: July 11, 2001
Last Updated: April 23, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institutes of Health Clinical Center (CC):
unspecified adult solid tumor, protocol specific

ClinicalTrials.gov processed this record on April 15, 2014