18F-FLT-PET in Predicting Response in Patients with Metastatic Breast Cancer to the Brain Undergoing Whole Brain Radiation Therapy

Status: complete

This pilot clinical trial studies how well fluorothymidine F-18 (18F-FLT)-positron emission tomography (PET) works compared to magnetic resonance imaging (MRI) in predicting response in patients with breast cancer that has spread from the original (primary) tumor to the brain and are undergoing whole-brain radiotherapy. The FLT-PET scan uses the special radioactive substance, 18F-FLT, which builds up in cells that are increasing in number, including cancer cells. The radiation that it gives off as it breaks down helps make clear three-dimensional pictures of tumors during PET scans. MRI is a procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. Comparing results of diagnostic procedures done before and after treatment may help doctors predict a patient's response to treatment and help plan the best treatment.

Inclusion Criteria

Histologically-confirmed (confirmation done at Memorial Sloan-Kettering Cancer Center [MSKCC]) metastatic adenocarcinoma of the breast
Radiologic evidence of new and/or progressive brain metastases (>= 10 mm in longest dimension) by MRI imaging of the brain
Planned WBRT based on number (>= 3 lesions) and/or size (>= 1 cm) of brain metastases
Patients who require additional clinically indicated stereotactic radiosurgery (SRS) in addition to WBRT will also be eligible
Life expectancy of > 12 weeks
Karnofsky performance status (KPS) >= 70%
Creatinine =< 2.0 times the upper limit of normal
Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to enrollment, must be non-lactating and must agree to use adequate contraception prior to enrollment and for the duration of study participation
No limit to prior therapies with last anti-cancer treatment >= 2 weeks from initiation of WBRT; please note: there is no washout period required for trastuzumab, pertuzumab for patients who have developed new parenchymal brain metastases while on these agents

Exclusion Criteria

Leptomeningeal metastases; please note: leptomeningeal metastases may be allowed if it is limited to cranial metastasis (MRI spine should be completed, within 4 weeks of enrollment, to show that no other leptomeningeal metastases is present) and is not the only metastasis present in the brain
Concurrent administration of lapatinib or other tyrosine kinase inhibitors other than sorafenib
Craniotomy or any other major surgery, open biopsy, or significant traumatic injury within 4 weeks of randomization
Concurrent anti-cancer therapy (chemotherapy, hormonal therapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) other than sorafenib, and protocol-specified whole-brain radiotherapy
Use of any investigational drug within 30 days or 5 half-lives, whichever is longer, preceding enrollment
Inability to comply with protocol and/or not willing or not available for follow-up assessments
Any condition which in the investigator’s opinion makes the patient unsuitable for the study participation
Patient is incontinent of urine or stool (which would make them unable to tolerate lying still for 60 minutes)
Claustrophobia
Known allergic reaction to gadopentetate dimeglumine (Gd-DTPA)
Renal insufficiency with recent (< 3 month old) creatinine > 2.0
Any contraindication to MRI (e.g., pacemaker, aneurysm clip, tissue expander)

PRIMARY OBJECTIVES:

I. To examine the radiographic response to whole-brain radiotherapy (WBRT) by FLT-PET and MRI for each cohort of 10 patients separately.

II. To examine and quantify changes in response as assessed by serial FLT PET images taken over the course of treatment for each cohort of 10 patients separately.

SECONDARY OBJECTIVES:

I. To correlate treatment response as measured by FLT-PET with response assessment based on MRI of the brain in all patients and assess duration of response (i.e., central nervous system [CNS] progression-free survival) during follow-up with magnetic resonance (MR) imaging.

TERTIARY OBJECTIVES:

I. To correlate the ability of FLT-PET and MRI of the brain imaging to differentiate viable tumor, inflammation and necrosis with surgical resection specimens (if available) obtained in patients with a medical indication for craniotomy.

OUTLINE:

Patients receive fluorothymidine F-18 intravenously (IV) and then undergo 18F-FLT-PET over 60-90 minutes at baseline (within 4 weeks of treatment), 7-10 days post-treatment and then 10-12 weeks after treatment. Patients also undergo MRI at baseline and then 10-12 weeks after WBRT.

After completion of study, patients are followed up every 3 months for 1 year and every 6 months thereafter.

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18F-FLT-PET in Predicting Response in Patients with Metastatic Breast Cancer to the Brain Undergoing Whole Brain Radiation Therapy

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