Trial Outcomes & Findings for The Role of Gadoxetate (Eovist) Enhanced CT in Evaluating Cholangiocarcinoma (NCT NCT01673802)

Results Overview

CT scans were assessed for tumor visualization after use of Gadoxetate disodium

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

18 participants

Primary outcome timeframe

24 hrs

Results posted on

2017-06-01

Participant milestones
Measure	Gadoxetate Uptake in CT Imaging Patients will undergo a standard of care Gadoxetate (Eovist 0.025 mmol/kg) MRI for cholangiocarcinoma. Patients will then be immediately placed on the CT scanner. Patients will undergo a dual energy CT of the abdomen with no additional contrast. After the first 8 subjects were accrued, it was apparent that the standard clinical dose was suboptimal for visualization on rsDECT. After obtaining additional regulatory approvals including an investigative New Drug (IND) letter from the FDA, as well as new approval from our institution's IRB, all subsequent subjects were scanned with 0.05 mmol/kg Gadoxetate Disodium. Both groups were injected with Gadoxetate Disodium at a rate of 1 ml/s.
Gadoxetate Standard Dose 0.025 mmol/kg STARTED	8
Gadoxetate Standard Dose 0.025 mmol/kg COMPLETED	8
Gadoxetate Standard Dose 0.025 mmol/kg NOT COMPLETED	0
Gadoxetate Double Dose 0.050 mmol/kg STARTED	10
Gadoxetate Double Dose 0.050 mmol/kg COMPLETED	10
Gadoxetate Double Dose 0.050 mmol/kg NOT COMPLETED	0

Withdrawal data not reported

The Role of Gadoxetate (Eovist) Enhanced CT in Evaluating Cholangiocarcinoma

Baseline characteristics by cohort
Measure	Gadoxetate Uptake in CT Imaging n=18 Participants Patients will undergo a standard of care Gadoxetate (Eovist 0.025 mmol/kg) MRI for cholangiocarcinoma. Patients will then be immediately placed on the CT scanner. Patients will undergo a dual energy CT of the abdomen with no additional contrast. After the first 8 subjects were accrued, it was apparent that the standard clinical dose was suboptimal for visualization on rsDECT. After obtaining additional regulatory approvals including an investigative New Drug (IND) letter from the FDA, as well as new approval from our institution's IRB, all subsequent subjects were scanned with 0.05 mmol/kg Gadoxetate Disodium. Both groups were injected with Gadoxetate Disodium at a rate of 1 ml/s.
Age, Continuous	54.9 years n=99 Participants
Sex: Female, Male Female	7 Participants n=99 Participants
Sex: Female, Male Male	11 Participants n=99 Participants
Region of Enrollment United States	18 participants n=99 Participants

Timeframe: 24 hrs

Population: Number of Subjects Where Hilar Cholangiocarcinomas Could be Visualized Using Gadoxetate Disodium Enhanced Dual Energy CT

CT scans were assessed for tumor visualization after use of Gadoxetate disodium

Outcome measures
Measure	Gadoxetate Uptake in CT Imaging n=18 Participants Patients will undergo a standard of care Gadoxetate (Eovist 0.025 mmol/kg) MRI for cholangiocarcinoma. Patients will then be immediately placed on the CT scanner. Patients will undergo a dual energy CT of the abdomen with no additional contrast. After the first 8 subjects were accrued, it was apparent that the standard clinical dose was suboptimal for visualization on rsDECT. After obtaining additional regulatory approvals including an investigative New Drug (IND) letter from the FDA, as well as new approval from our institution's IRB, all subsequent subjects were scanned with 0.05 mmol/kg Gadoxetate Disodium. Both groups were injected with Gadoxetate Disodium at a rate of 1 ml/s.
Number of Subjects Where Hilar Cholangiocarcinomas Could be Visualized Using Gadoxetate Disodium Enhanced Dual Energy CT	5 participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

University of Alabama at Bimringham

Phone: 205-996-4132