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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


N/A
18 Years
N/A
Open (Enrolling)
Both
Metastatic Breast Cancer to the Brain

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Trial Information

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


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.

Exclusion Criteria:

- Leptomeningeal metastases

- 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

radiographic response

Outcome Description:

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.

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Andrew Seidman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

12-039

NCT ID:

NCT01621906

Start Date:

June 2012

Completion Date:

June 2014

Related Keywords:

  • Metastatic Breast Cancer to the Brain
  • Breast
  • brain metastases
  • 18F-FLT-PET Imaging
  • FLT(3'DEOXY-3'FLUOROTHYMIDINE)
  • MR Imaging
  • 12-039
  • Breast Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021