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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional relevant MeSH terms:
Neoplasms
Fluorodeoxyglucose F18
Radiopharmaceuticals
Diagnostic Uses of Chemicals
Pharmacologic Actions
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014