Trial Outcomes & Findings for Feasibility Study of Vessel Analysis for Noninvasive Diagnosis of Malignancy in Breast Tumors (NCT NCT00630292)

Results Overview

Amount of vessel tortuosity before the start of neoadjuvant chemotherapy and at the end of neoadjuvant chemotherapy

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

6 participants

Primary outcome timeframe

up to two weeks prior to start of chemotheraphy

Results posted on

2010-05-18

Participant Flow

Participant milestones

Participant milestones
Measure	Breast Magnetic Resonance Angiography Women who had a Magnetic Resonance Angiography sequence added to a clinical breast MRI
Overall Study STARTED	6
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Breast Magnetic Resonance Angiography Women who had a Magnetic Resonance Angiography sequence added to a clinical breast MRI
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Feasibility Study of Vessel Analysis for Noninvasive Diagnosis of Malignancy in Breast Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Breast Magnetic Resonance Angiography n=6 Participants Women who had a Magnetic Resonance Angiography sequence added to a clinical breast MRI
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age Continuous	45.5 years STANDARD_DEVIATION 5.49 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants

PRIMARY outcome

Timeframe: up to two weeks prior to start of chemotheraphy

Population: Blood vessels could not be detected for any of the subjects due to spatial resolution limits of MRI scanner for breast MRI and therefore measurement of blood vessel angularity could not be performed.

Amount of vessel tortuosity before the start of neoadjuvant chemotherapy and at the end of neoadjuvant chemotherapy

Outcome measures

Outcome data not reported

Adverse Events

Breast Magnetic Resonance Angiography

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

William Irvin, Jr. MD / Co-Principal Investigator

University of North Carolina

Phone: 919-966-6735

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place