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CompletedNCT00019565Updated Sep 26, 2016

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

A Phase 1 interventional study of magnetic resonance imaging and positron emission tomography in Unspecified Adult Solid Tumor, Protocol Specific, sponsored by National Institutes of Health Clinical Center (CC). Completed at 1 site in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2016-09-26.

Sponsored by National Institutes of Health Clinical Center (CC) · Phase 1, Interventional, and Diagnostic

Phase
Phase 1
Study type
Interventional
Enrollment
53
Ages
18 Years to 120 Years
Sex
All
01

Study summary

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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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.

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Conditions studied

  • Unspecified Adult Solid Tumor, Protocol Specific

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Keywords

  • unspecified adult solid tumor, protocol specific
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 53 is close to the median of 50 across 7,253 interventional studies indexed under Neoplasms.

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Lead sponsor

National Institutes of Health Clinical Center (CC) is the lead sponsor of 367 studies on the registry; 27 are open to participants now.

Of its 22 completed or terminated interventional studies of FDA-regulated products, 18 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Phase
Phase 1
Primary purpose
Diagnostic
Enrollment
53 participants (actual)

Interventions

  • Proceduremagnetic resonance imaging
  • Procedurepositron emission tomography
  • Radiationfludeoxyglucose F 18
06

Study locations

1 site
  • Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
    Bethesda, Maryland 20892-1182, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 26, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00019565
Lead sponsor
National Institutes of Health Clinical Center (CC)
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jan 27, 2003
Start date
Oct 1998
Primary completion
Aug 2008
Last update
Sep 26, 2016

Study contacts

Steven K. Libutti, MD
study chair · NCI - Surgery Branch
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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