A Comparison of MRI Perfusion and FDG PET/CT to Distinguish Between Radiation Injury and Tumor Progression

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01604512
First received: May 21, 2012
Last updated: August 25, 2014
Last verified: August 2014
  Purpose

This study will examine if MRI perfusion and PET/CT can tell growing tumor and radiation injury apart. MRI perfusion looks at the blood vessels in the tumor. PET/CT looks if the tumor cells are actively growing. The investigators will do these two tests and see which one is better.


Condition Intervention
Brain Cancer
Other: MRI perfusion and PET/CT scans

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Enhancing Brain Lesions After Radiation Therapy: A Comparison of MRI Perfusion and FDG PET/CT to Distinguish Between Radiation Injury and Tumor Progression

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • imaging techniques [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To assess the utility of PET/CT and MRI perfusion studies in predicting whether worsening enhancing brain lesions seen after radiation therapy represent radiation injury or tumor progression. This study will examine the role of these two imaging techniques in predicting diagnosis and treatment planning.


Secondary Outcome Measures:
  • predicting tumor progression [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To assess the utility of PET and MRI perfusion studies in predicting tumor progression in patients with tumors with a history of brain radiation therapy receiving anti-angiogenic therapy (such as bevacizumab).


Estimated Enrollment: 84
Study Start Date: May 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pts with a brain tumor
The study will prospectively enroll patients who have increasing size and/or enhancement of brain lesion(s) after brain radiation therapy for a neoplasm (either primary or metastatic), where it is unclear if a lesion represents radiation injury or progressive tumor.
Other: MRI perfusion and PET/CT scans
The MRI perfusion and PET/CT scans will be obtained within 12 weeks of each other. These scans are part of the standard of care for patients with brain tumors and uncertain tumor response or progression after treatment. Although every effort will be made to perform both MRI perfusion and PET/CT on the same day or during the same week, some patients may experience longer intervals between scans due to scheduling conflicts. The disease in question (radiation injury vs. tumor progression) may change slightly during this interval (e.g., the lesion may grow or shrink slightly), but no large changes are expected between the two scans. The patients may continue existing treatments in the interval between scans (e.g., steroids, chemotherapy), but the two scans must be performed before any change or new treatment occurs. Fusion images of MRI and PET/CT will not be reviewed by the neuroradiologist interpreting the MRI perfusion nor the nuclear medicine radiologist interpreting the PET/CT.

  Eligibility

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

Inclusion Criteria:

  • Pathological or clinical/radiological diagnosis of aneoplasm , either primary (e.g., malignant glioma) or secondary (metastasis from systemic malignancy) with a history of brain radiation therapy
  • Completed fractionated radiation therapy (to 60 Gy for high grade gliomas) or stereotactic radiosurgery or hypofractionated radiation therapy (e.g. for brain metastases, anaplastic meningiomas), without or with concurrent chemotherapy
  • New or increased enhancing brain lesion(s) OR nonenhancing brain lesion(s) if receiving anti-angiogenic therapy, which is considered indeterminate for tumor progression vs. radiation injury by the neuroradiologist or clinician
  • Patient and/or guardian is able to provide written informed consent prior to study registration
  • Age ≥ 18 years old

Exclusion Criteria:

  • Claustrophobia
  • Known allergic reaction to Gd-DTPA
  • Renal insufficiency with recent (< 3 month old) creatinine > 2.0
  • Any contraindication to MRI (e.g., pacemaker, aneurysm clip, tissue expander).
  • Pregnant or nursing female
  • Unable to cooperate for MRI and/or PET/CT
  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: NCT01604512

Contacts
Contact: Robert Young, MD 212-639-8196
Contact: Antonio Omuro, MD 212-639-7523

Locations
United States, New Jersey
Memorial Sloan-Kettering Cancer Center at Basking Ridge Recruiting
Basking Ridge, New Jersey, United States
Contact: Robert Young, MD    212-639-8196      
United States, New York
Memorial Sloan-Kettering Cancer Center at Commack Recruiting
Commack, New York, United States, 11725
Contact: Robert Young, MD    212-639-8196      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Robert Young, MD    212-639-8196      
Contact: Antonio Omuro, MD    212-639-7523      
Principal Investigator: Robert Young, MD         
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Robert Young, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01604512     History of Changes
Other Study ID Numbers: 12-067
Study First Received: May 21, 2012
Last Updated: August 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Brain tumor
MRI Perfusion
FDG PET/CT
12-067

Additional relevant MeSH terms:
Brain Neoplasms
Radiation Injuries
Brain Diseases
Central Nervous System Diseases
Central Nervous System Neoplasms
Neoplasms
Neoplasms by Site
Nervous System Diseases
Nervous System Neoplasms
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014