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Enhancing Brain Lesions After Radiation Therapy: A Comparison of MRI Perfusion and FDG PET/CT to Distinguish Between Radiation Injury and Tumor Progression


N/A
18 Years
N/A
Open (Enrolling)
Both
Brain Cancer

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Trial Information

Enhancing Brain Lesions After Radiation Therapy: A Comparison of MRI Perfusion and FDG PET/CT to Distinguish Between Radiation Injury and Tumor Progression


Inclusion Criteria:



- Pathological or clinical/radiological diagnosis of a brain mass, either primary
(e.g., malignant glioma) or secondary (metastasis from systemic malignancy)

- 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

imaging techniques

Outcome Description:

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.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Robert Young, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

12-067

NCT ID:

NCT01604512

Start Date:

May 2012

Completion Date:

May 2014

Related Keywords:

  • Brain Cancer
  • Brain tumor
  • MRI Perfusion
  • FDG PET/CT
  • 12-067
  • Brain Neoplasms
  • Radiation Injuries
  • Neoplastic Processes

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Memorial Sloan-Kettering Cancer Center at Basking RidgeBasking Ridge, New Jersey  07920
Memorial Sloan-Kettering Cancer Center at CommackCommack, New York  11725