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

This study is currently recruiting participants.
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

November 11, 2013
November 15, 2013
March 2011
November 2015   (final data collection date for primary outcome measure)
Number of Adverse Events [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01985971 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
F18 EF5 PET/CT Imaging in Patients With Brain Metastases From Breast Cancer
F18 EF5 PET/CT Imaging in Patients With Brain Metastases From Breast Cancer

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.

Not Provided
Interventional
Not Provided
Primary Purpose: Diagnostic
Brain Metastases From Breast Cancer
Radiation: PET/CT Imaging
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
25
November 2015
November 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Lilie Lin, MD 855-216-0098 PennCancerTrials@emergingmed.com
United States
 
NCT01985971
UPCC 15910
Yes
Abramson Cancer Center of the University of Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Not Provided
Not Provided
Abramson Cancer Center of the University of Pennsylvania
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP