Trial Outcomes & Findings for Intra-op Detection of Occult Ovarian Carcinoma Using a Folate-Alpha Receptor Specific Fluorescent Ligand (NCT NCT01511055)

Last Updated: 2020-11-12

Results Overview

A maximum of 5 nodules less than 1cm in size will be identified in each patient with the naked eye and then visualized with the camera. The nodules will be biopsied after determining if they are fluorescent positive or negative (F+ or F-), and examined microscopically to confirm if carcinoma is present. Up to 5 F+ lesions that were not identified with the naked eye will also be biopsied and examined microscopically to determine if carcinoma is present. These data will establish the sensitivity and specificity of this technique using microscopic analysis as the gold standard.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

27 participants

Primary outcome timeframe

1 week

Results posted on

2020-11-12

Participant Flow

Participant milestones

Participant milestones
Measure	Folate-FITC EC-17: One-time dose of Folate-FITC (EC-17), 0.1mg/kg IV 2-3 hours prior to surgery.
Overall Study STARTED	27
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Folate-FITC EC-17: One-time dose of Folate-FITC (EC-17), 0.1mg/kg IV 2-3 hours prior to surgery.
Overall Study Withdrawal by Subject	6

Baseline Characteristics

Intra-op Detection of Occult Ovarian Carcinoma Using a Folate-Alpha Receptor Specific Fluorescent Ligand

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Folate-FITC n=27 Participants EC-17: One-time dose of Folate-FITC (EC-17), 0.1mg/kg IV 2-3 hours prior to surgery.
Age, Customized Age 40-49	3 Participants n=5 Participants
Age, Customized Age 50-59	6 Participants n=5 Participants
Age, Customized Age 60-69	9 Participants n=5 Participants
Age, Customized Age 70-79	9 Participants n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 week

Population: The investigational camera was instrumental for collecting data for this study. Due to technical problems with the camera from the onset of the study, the study was terminated and no data was able to be collected or analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Duration of hospitalization with a maximum of 7 days

Study participants will be followed and all adverse events will be captured for the duration of hospitalization following administration of investigational product, up to a maximum of 7 days following IP administration and surgical procedure. Adverse Events will be classified as: grade 1=Mild, grade 2=Moderate, grade 3=Severe, grade 4=Life-threatening/disabling, grade 5 =Death. Significant is defined as adverse events grade 4 or higher.

Outcome measures

Outcome measures
Measure	Folate-FITC n=27 Participants EC-17: One-time dose of Folate-FITC (EC-17), 0.1mg/kg IV 2-3 hours prior to surgery.
Number of Participants With Grade 4 or Higher Adverse Events Following a One-time Dose of Folate-FITC (EC-17).	0 Participants

Adverse Events

Folate-FITC

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Folate-FITC n=27 participants at risk EC-17: One-time dose of Folate-FITC (EC-17), 0.1mg/kg IV 2-3 hours prior to surgery.
Respiratory, thoracic and mediastinal disorders Sneezing, spontaneous onset	11.1% 3/27 • Number of events 3 • Adverse events were collected from the period from the initiation of any study procedures to the end of the study treatment follow-up, approximately one week
Gastrointestinal disorders Tingling sensation in mouth, palate and molars	11.1% 3/27 • Number of events 3 • Adverse events were collected from the period from the initiation of any study procedures to the end of the study treatment follow-up, approximately one week
Vascular disorders Mild facial flusing	7.4% 2/27 • Number of events 2 • Adverse events were collected from the period from the initiation of any study procedures to the end of the study treatment follow-up, approximately one week
Respiratory, thoracic and mediastinal disorders Sinus pressure	7.4% 2/27 • Number of events 2 • Adverse events were collected from the period from the initiation of any study procedures to the end of the study treatment follow-up, approximately one week
Ear and labyrinth disorders Plugged ears	3.7% 1/27 • Number of events 1 • Adverse events were collected from the period from the initiation of any study procedures to the end of the study treatment follow-up, approximately one week
Gastrointestinal disorders Strong taste in mouth	3.7% 1/27 • Number of events 1 • Adverse events were collected from the period from the initiation of any study procedures to the end of the study treatment follow-up, approximately one week
Skin and subcutaneous tissue disorders Cirumoral and Nasal Pruritus	3.7% 1/27 • Number of events 1 • Adverse events were collected from the period from the initiation of any study procedures to the end of the study treatment follow-up, approximately one week
Nervous system disorders Migraine	3.7% 1/27 • Number of events 1 • Adverse events were collected from the period from the initiation of any study procedures to the end of the study treatment follow-up, approximately one week
Psychiatric disorders Anxiety	3.7% 1/27 • Number of events 1 • Adverse events were collected from the period from the initiation of any study procedures to the end of the study treatment follow-up, approximately one week

Additional Information

Sean C. Dowdy, M.D.

Mayo Clinic

Phone: 507-266-0225

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place