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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01621906
First received: June 14, 2012
Last updated: June 12, 2014
Last verified: June 2014
  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.


Condition Intervention
Metastatic Breast Cancer to the Brain
Device: 18F-FLT-PET Imaging

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Pilot Study of 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • radiographic response [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    by two modalities: FLT-PET and MRI. MRI is considered standard of care and response assessments are recorded as CR, PR, PD, SD, and unknown (see section 12.0). FLT-PET response assessments will be recorded as SUV-MAX and a decline by 25% is considered as significant (see Section 12.0). MRI measurements will be recorded at baseline and 10 to 12 weeks post WBRT. FLT-PET measurements will be recorded at baseline, 10 days post WBXRT, and 10-12 weeks post WBXRT.


Secondary Outcome Measures:
  • Analysis of surgical specimen [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Comparing FLT PET findings with tissue analysis will enable us to determine if imaging results are concordant with histological findings and thus allow for confirmation of this hypothesis. In this manner, we propose to generate a bridge between tissue analysis and FLT-PET brain imaging studies. For patients needing to undergo craniotomy for resection of a brain metastasis after WBRT, tissue findings (radionecrosis versus viable tumor) will be correlated with radiologic assessment in an exploratory manner.


Estimated Enrollment: 20
Study Start Date: June 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
Cohort 1 will include the first ten patients treated with WBRT concomitantly with sorafenib (on a separate phase I trial). We will perform a pilot study of serial FLT-PET imaging of the brain at baseline (< 4 weeks prior to initiation of WBRT), up to 7-10 days post-WBRT and 10-12 weeks after WBRT in patients with metastatic breast cancer to the brain (N=20) treated with WBRT with or without sorafenib.
Device: 18F-FLT-PET Imaging

All patients will be imaged using FLT-PET scans at baseline (within 4 weeks of initiation of WBRT), 7-10 days after completion of WBRT and then 10-12 weeks after WBRT.

Patients will also be evaluated with MRI imaging at baseline and then 10-12 weeks after WBRT.

Patients will be followed with MRI every 3 months (+/- 7 days) for the first year and then every 6 months (+/- 7 days) thereafter which is the standard of care.

Experimental: Cohort 2
Cohort 2 will include patients treated with standard WBRT alone. Patients in both these cohorts will also be assessed with standard non-invasive MRI in addition to [18F] FLT PET at baseline (< 4 weeks of WBRT) and 10-12 weeks after completion of WBRT.
Device: 18F-FLT-PET Imaging

All patients will be imaged using FLT-PET scans at baseline (within 4 weeks of initiation of WBRT), 7-10 days after completion of WBRT and then 10-12 weeks after WBRT.

Patients will also be evaluated with MRI imaging at baseline and then 10-12 weeks after WBRT.

Patients will be followed with MRI every 3 months (+/- 7 days) for the first year and then every 6 months (+/- 7 days) thereafter which is the standard of care.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT01621906

Contacts
Contact: Andrew Seidman, MD 646-888-5445
Contact: Heiko Schoder, MD 212-639-2079

Locations
United States, New Jersey
Memoral Sloan Kettering Cancer Center Recruiting
Basking Ridge, New Jersey, United States
Contact: Andrew Seidman, MD    646-888-5445      
United States, New York
Memorial Sloan-Kettering Cancer Center @ Suffolk Recruiting
Commack, New York, United States, 11725
Contact: Andrew Seidman, MD    646-888-5445      
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Andrew Seidman, MD    646-888-5445      
Contact: Heiko Schoder, MD    212-639-2079      
Principal Investigator: Andrew Seidman, MD         
Memorial Sloan-Kettering at Mercy Medical Center Recruiting
Rockville Centre, New York, United States
Contact: Andrew Seidman, MD    646-888-5445      
Memoral Sloan Kettering Cancer Center@Phelps Memorial Hospital Recruiting
Sleepy Hollow, New York, United States
Contact: Andrew Seidman, MD    646-888-5445      
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Andrew Seidman, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01621906     History of Changes
Other Study ID Numbers: 12-039
Study First Received: June 14, 2012
Last Updated: June 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Breast
brain metastases
18F-FLT-PET Imaging
FLT(3'DEOXY-3'FLUOROTHYMIDINE)
MR Imaging
12-039

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Sorafenib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 01, 2014