Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

F18 EF5 PET/CT Imaging in Patients With Brain Metastases From Breast Cancer

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania Identifier:
First received: November 11, 2013
Last updated: December 14, 2015
Last verified: December 2015
To estimate the presence of hypoxia in individual lesions after radiotherapy in patients with brain metastases from breast cancer as identified by F18 EF5 PET/CT imaging.

Condition Intervention
Brain Metastases From Breast Cancer
Radiation: PET/CT Imaging

Study Type: Interventional
Study Design: Primary Purpose: Diagnostic
Official Title: F18 EF5 PET/CT Imaging in Patients With Brain Metastases From Breast Cancer

Resource links provided by NLM:

Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:

Primary Outcome Measures:
  • Number of Adverse Events [ Time Frame: 2 year ]

Estimated Enrollment: 25
Study Start Date: March 2011
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects with measurable brain metastases of at least 1 cm in any plane based on anatomic imaging.
  • Subjects with prior resection of brain metastases with progressions on brain MRI.
  • Histologic confirmation of breast cancer.
  • Age of study subject must be > 18 years.
  • ECOG Performance Status ≤ 2.
  • Ability to undergo brain MR and PET imaging
  • Study subjects must have normal organ and marrow function as defined below:

WBC >2,000/mmᶟ, platelets >90,000/mmᶟ, total bilirubin <2.0 mg/dl, creatinine <2.0 mg/dl.

  • The effects of EF5 on the developing human fetus are unknown. For this reason, women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation (1 month). Should a woman become pregnant pr suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Women of childbearing potential will have a urine pregnancy test the day of the F18 -EF5 PET scan prior to the F18 -EF5 injection.
  • Ability to understand, participate and provide a documented signed informed consent.
  • Subjects who are allergic to gadolinium will have MRI scans without gadolinium contrast.

Exclusion Criteria:

  • History of allergic reactions attributed to Flagyl (metronidazole), which has a chemical structure similar to EF5.
  • Pregnant women are excluded because EF5 has an unknown risk for adverse events in fetuses and nursing infants secondary the administration of EF5 to the mother. Breastfeeding should be discontinued if EF5 is administered to the mother.
  • Subject has any other condition or personal circumstance that, in the judgement of the investigator, might interfere with the collection of complete good quality data.
  • Subjects who are unable to provide informed consent.
  • Patients with prior whole brain radiotherapy.
  • Patients with moderate to severe renal failure, defined as estimated GFR less than 30 ml/Lmin 1.73m²
  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 identifier: NCT01985971

United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Principal Investigator: Lilie Lin, MD Abramson Cancer Center of the University of Pennsylvania
  More Information

Responsible Party: Abramson Cancer Center of the University of Pennsylvania Identifier: NCT01985971     History of Changes
Other Study ID Numbers: UPCC 15910
Study First Received: November 11, 2013
Last Updated: December 14, 2015

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasm Metastasis
Brain Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases processed this record on May 22, 2017