Trial Outcomes & Findings for Assessing Response to Neoadjuvant Chemotherapy With HD PET/CT, Serum Glycomic Markers and Tissue Muc-1 Isoforms (NCT NCT01110174)

Results Overview

Patients will have a HD PET/CT at baseline and another after the first cycle of NAC and upon completion.The goal is to distinguish NAC responders from non-responders and to accurately identify the size and extent of residual disease.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

8 participants

Primary outcome timeframe

After the first cycle of Neoadjuvant chemotherapy (NAC)

Results posted on

2019-11-21

Participant Flow

Participant milestones

Participant milestones
Measure	HD PET/CT utilization of PET/CT for diagnostic of breast cancer progression. HD PET/CT: imaging
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Assessing Response to Neoadjuvant Chemotherapy With HD PET/CT, Serum Glycomic Markers and Tissue Muc-1 Isoforms

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HD PET/CT n=8 Participants utilization of PET/CT for diagnostic of breast cancer progression. HD PET/CT: imaging
Age, Categorical <=18 years	NA Participants n=5 Participants
Age, Categorical Between 18 and 65 years	NA Participants n=5 Participants
Age, Categorical >=65 years	NA Participants n=5 Participants
Sex: Female, Male Female	NA Participants n=5 Participants
Sex: Female, Male Male	NA Participants n=5 Participants
Region of Enrollment United States	NA participants n=5 Participants

PRIMARY outcome

Timeframe: After the first cycle of Neoadjuvant chemotherapy (NAC)

Population: PI has left the institution, all efforts to locate PI and obtain this information have been exhausted and there is no access to this data

Patients will have a HD PET/CT at baseline and another after the first cycle of NAC and upon completion.The goal is to distinguish NAC responders from non-responders and to accurately identify the size and extent of residual disease.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, during and after chemotherapy

Population: PI has left institution, all efforts to locate secondary outcome measure data have been exhausted and there is no longer access to this data.

Outcome measures

Outcome data not reported

Adverse Events

HD PET/CT

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

PI has left the institution, all efforts to locate PI have been exhausted.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place