Trial Outcomes & Findings for Pilot Study to Evaluate High Resolution PET Image-Guidance for Sampling of Breast Abnormalities (NCT NCT00606931)

Results Overview

Success in completion of the PET guided biopsy of a suspicious lesion was determined by 1. Alteration in lesion morphology (no change in vs change in lesion morphology) after sampling AND/OR 2. Visualization of regions with high radioactive uptake within the biopsy specimen consistent with target lesion (focal uptake present vs absent).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

22 participants

Primary outcome timeframe

within two days of obtaining histopathology of the lesion biopsied

Results posted on

2009-07-07

Participant Flow

Patients were recruited between January \& July 2008 at the medical center where they underwent PEM imaging.

The first enrolled participant was excluded from the analysis, the subject signed the consent form prior to the trial being officially released.

Participant milestones

Participant milestones
Measure	PET Guided Biopsy No comparison group. All enrolled participants were expected to undergo PET guided biopsy.
Overall Study STARTED	22
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	PET Guided Biopsy No comparison group. All enrolled participants were expected to undergo PET guided biopsy.
Overall Study Withdrawal by Subject	3

Baseline Characteristics

Pilot Study to Evaluate High Resolution PET Image-Guidance for Sampling of Breast Abnormalities

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PET Guided Biopsy n=22 Participants No comparison group. All enrolled participants were expected to undergo PET guided biopsy.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Age Continuous	58.5 years STANDARD_DEVIATION 11.9 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants

PRIMARY outcome

Timeframe: within two days of obtaining histopathology of the lesion biopsied

Population: All participants who completed the PET-guided biopsy for a suspicious lesions. 24 lesions were biopsied in 19 participants

Success in completion of the PET guided biopsy of a suspicious lesion was determined by 1. Alteration in lesion morphology (no change in vs change in lesion morphology) after sampling AND/OR 2. Visualization of regions with high radioactive uptake within the biopsy specimen consistent with target lesion (focal uptake present vs absent).

Outcome measures

Outcome measures
Measure	PET Guided Biopsy n=19 Participants No comparison group. All enrolled participants were expected to undergo PET guided biopsy.
Number of Lesions That Were Successfully Biopsied Using the PET-guided Biopsy Method.	24 Number of lesions

SECONDARY outcome

Timeframe: Within one week of completing PET-guided biopsy

Serious Adverse Events are defined as events that * Are fatal or life-threatening * Require in-patient hospitalization or prolong hospitalization * Result in permanent or significant disability/incapacity * Result in congenital abnormality/birth defect

Outcome measures

Outcome measures
Measure	PET Guided Biopsy n=19 Participants No comparison group. All enrolled participants were expected to undergo PET guided biopsy.
Number of Participants Who Reported Serious Adverse Events After the PET-Guided Biopsy	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Within one week of completing PET-guided biopsy

Participants who could tolerate the procedure and complete it. This was ascertained by patient feedback questionnaire asking for overall discomfort rating from 0 to 5, where 0 is no discomfort and 5 was assigned to acute discomfort that prevented subject from completing the procedure.

Outcome measures

Outcome measures
Measure	PET Guided Biopsy n=19 Participants No comparison group. All enrolled participants were expected to undergo PET guided biopsy.
Number of Participants Who Tolerated the PET-Guided Biopsy Procedure	19 Participants

Adverse Events

PET Guided Biopsy

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	PET Guided Biopsy No comparison group. All enrolled participants were expected to undergo PET guided biopsy.
Investigations Nausea	5.3% 1/19 • Number of events 1
Injury, poisoning and procedural complications Bruising	5.3% 1/19 • Number of events 1

Additional Information

Judith E Kalinyak, MD, PhD, Medical Director

Naviscan Inc

Phone: 858-587-3641

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results pending FDA approval or clearance.
Publication restrictions are in place

Restriction type: OTHER