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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Abramson Cancer Center of the University of Pennsylvania
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01985971
First received: November 11, 2013
Last updated: November 15, 2013
Last verified: November 2013
  Purpose

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 25
Study Start Date: March 2011
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
  Eligibility

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

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 ClinicalTrials.gov identifier: NCT01985971

Contacts
Contact: Lilie Lin, MD 855-216-0098 PennCancerTrials@emergingmed.com

Locations
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Lilie Lin, MD    855-216-0098    PennCancerTrials@emergingmed.com   
Principal Investigator: Lilie Lin, MD         
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
  More Information

No publications provided

Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01985971     History of Changes
Other Study ID Numbers: UPCC 15910
Study First Received: November 11, 2013
Last Updated: November 15, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasm Metastasis
Brain Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 28, 2014