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OpenTrials
Completed

NCT Number: NCT00019565

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

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.

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Key information

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Bethesda, Maryland, 20892-1182, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnetic Resonance Imaging

Procedure

Positron Emission Tomography

Procedure

fludeoxyglucose F 18

Radiation

Sponsors and collaborators

Lead sponsor

National Institutes of Health Clinical Center (CC)

Nih

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study 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

Important dates

Study start
1998
Primary completion
2008
First posted
Jan 27, 2003
Registry last updated
Sep 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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