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

NCT01985971 | Completed Results DMC

• 1 other identifier: UPCC 15910
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain Metastases From Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events

  2 year

Study Arms (1)

EF5

EXPERIMENTAL

Radiation: PET/CT Imaging

Interventions

PET/CT Imaging RADIATION

EF5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Results Point of Contact

• Title: Lilie Lin, MD
• Organization: University of Pennsylvania

lin@xrt.upenn.edu

215-662-7267

Study Officials

• Lilie Lin, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2013
• First Posted: November 18, 2013
• Study Start: March 1, 2011
• Primary Completion: August 19, 2016
• Study Completion: August 19, 2016
• Last Updated: January 31, 2020
• Results First Posted: January 31, 2020

Record last verified: 2020-01

Locations

US (1)