Clinical Trial Finder

18F-FLT-PET Imaging of the Brain in Patients With Metastatic Breast Cancer to the Brain Treated With Whole Brain Radiation Therapy With or Without Sorafenib: Comparison With MR Imaging of the Brain

Study Purpose

The purpose of this study is to compare two different imaging methods to examine the response of brain metastases to WBRT. These two imaging methods will take pictures of the brain using : 1) a positron emission tomography (PET) scanner and 2) Magnetic Resonance Imaging (MRI) scanner. A PET scanner resembles a CT or MR scanner.PET scans use radioactive substances also called as radioactive markers to "see" cancer cells. We plan to use [18F]FLT as a radioactive marker. FLT is used to image tumor growth. FLT PET scan is a new clinical procedure. It is in the testing stage of development unlike FDG-PET which is used more commonly used. Therefore, this is considered a "research" study. This will help us evaluate whether this scan will be safe and better used in the future to evaluate tumors. The amount of radiation to the body is small. The radiation from the radiotracer drug will be gone from the body in a few hours. There is no radiation risk from the MRI scans. Additionally, we also plan to use MRI imaging of the brain. We expect that [18F]FLT PET is better when compared to MRI and will give us more information about the brain metastases after WBRT.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Study Type
Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Histologically-confirmed (confirmation done at 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.
  • - Age ≥18 years; males and females - 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 Gd-DTPA - Renal insufficiency with recent (<3 month old) creatinine >2.0

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT01621906

Phase 0: Exploratory study involving very limited human exposure to the drug to determine whether a drug is modulating its target.

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
N/A

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Memorial Sloan Kettering Cancer Center

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Other
Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Metastatic Breast Cancer to the Brain
Study Website: View Trial Website

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Memoral Sloan Kettering Cancer Center, Basking Ridge, New Jersey

Status

Recruiting

Address

Memoral Sloan Kettering Cancer Center

Basking Ridge, New Jersey,

Site Contact

Andrew Seidman, MD

646-888-5445

Memorial Sloan Kettering Monmouth, Middletown, New Jersey

Status

Recruiting

Address

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748

Site Contact

Andrew Seidman, MD

646-888-5445

Commack, New York

Status

Recruiting

Address

Memorial Sloan Kettering Cancer Center @ Suffolk

Commack, New York, 11725

Site Contact

Andrew Seidman, MD

646-888-5445

Memorial Sloan Kettering Cancer Center, New York, New York

Status

Recruiting

Address

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Site Contact

Andrew Seidman, MD

646-888-5445

Rockville Centre, New York

Status

Recruiting

Address

Memorial Sloan Kettering at Mercy Medical Center

Rockville Centre, New York,

Site Contact

Andrew Seidman, MD

646-888-5445

Memorial Sloan Kettering Westchester, West Harrison, New York

Status

Recruiting

Address

Memorial Sloan Kettering Westchester

West Harrison, New York, 10604

Site Contact

Andrew Seidman, MD

646-888-5445

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