Trial Outcomes & Findings for Role of Positron Emission Mammography (PEM) Flex Solo II Positron Emission Tomography (PET) Scanner in Evaluating Neoadjuvant Chemotherapy Response in Patients With Breast Cancer (NCT NCT01012440)

Results Overview

Comparison of tumor size pre chemotherapy and post chemotherapy represents the PEM data. There is no the response with MRI because the study was aborted and very few patients were involved.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

5 participants

Primary outcome timeframe

1-2 weeks post treatment onset

Results posted on

2015-07-27

Participant Flow

Participant milestones

Participant milestones
Measure	Beast Cancer Subjects Subject will have assessment of neoadjuvant chemotherapy treatment response by both MRI and PEM to compare methods PEM Flex Solo II PET Scanner: Subjects will receive bilateral (both sides) breast and axillary PEM scans. MRI scan: Subjects will receive bilateral (both sides) breast and axillary MRI scans.
Overall Study STARTED	5
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Beast Cancer Subjects Subject will have assessment of neoadjuvant chemotherapy treatment response by both MRI and PEM to compare methods PEM Flex Solo II PET Scanner: Subjects will receive bilateral (both sides) breast and axillary PEM scans. MRI scan: Subjects will receive bilateral (both sides) breast and axillary MRI scans.
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Role of Positron Emission Mammography (PEM) Flex Solo II Positron Emission Tomography (PET) Scanner in Evaluating Neoadjuvant Chemotherapy Response in Patients With Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Beast Cancer Subjects n=5 Participants Subject will have assessment of neoadjuvant chemotherapy treatment response by both MRI and PEM to compare methods PEM Flex Solo II PET Scanner: Subjects will receive bilateral (both sides) breast and axillary PEM scans. MRI scan: Subjects will receive bilateral (both sides) breast and axillary MRI scans.
Age, Continuous	50.8 years STANDARD_DEVIATION 6.98 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1-2 weeks post treatment onset

Population: This study has been terminated due to poor accrual.

Comparison of tumor size pre chemotherapy and post chemotherapy represents the PEM data. There is no the response with MRI because the study was aborted and very few patients were involved.

Outcome measures

Outcome measures
Measure	Beast Cancer Subjects n=3 Participants Subject will have assessment of neoadjuvant chemotherapy treatment response by both MRI and PEM to compare methods PEM Flex Solo II PET Scanner: Subjects will receive bilateral (both sides) breast and axillary PEM scans. MRI scan: Subjects will receive bilateral (both sides) breast and axillary MRI scans.
Reduction in Tumor Size PEM tumor size pre chemotherapy	25.67 mm Standard Deviation 7.5
Reduction in Tumor Size PEM tumor size post chemotherapy	9.67 mm Standard Deviation 16.7

Adverse Events

Beast Cancer Subjects

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. Kirti Kulkarni

University of Chicago

Phone: (773) 702-2781

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place