Trial Outcomes & Findings for Histologic Assessment of the Difference Between 18F-2-fluoro-2-deoxy_D-glucose Positron Emission Mammography(PEM) and Magnetic Resonance Imaging (MRI) of the Breast (NCT NCT01249157)

Results Overview

using pathology as the gold standard and descriptively compare it to the accuracy of breast MRI in an exploratory analysis which will generate data for future studies. The first 5 patients who consent to the study were used for training purposes only.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

6 participants

Primary outcome timeframe

2 years

Results posted on

2015-12-24

Participant Flow

Participant milestones

Participant milestones
Measure	Preoperative 18FDG PEM and MRI Female patients with recently diagnosed invasive or in situ breast cancer
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Preoperative 18FDG PEM and MRI Female patients with recently diagnosed invasive or in situ breast cancer
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Histologic Assessment of the Difference Between 18F-2-fluoro-2-deoxy_D-glucose Positron Emission Mammography(PEM) and Magnetic Resonance Imaging (MRI) of the Breast

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Preoperative 18FDG PEM and MRI n=1 Participants Female patients with recently diagnosed invasive or in situ breast cancer.The first 5 patients who consent to the study will be intended for training purposes only.
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: No data displayed because Outcome Measure has zero total participants analyzed.

using pathology as the gold standard and descriptively compare it to the accuracy of breast MRI in an exploratory analysis which will generate data for future studies. The first 5 patients who consent to the study were used for training purposes only.

Outcome measures

Outcome data not reported

Adverse Events

Preoperative 18FDG PEM and MRI

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Maxine Jochelson

Memorial Sloan Kettering

Phone: 646-888-4507

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place