Comparison of Contrast Agents in Liver MR for the Detection of Hepatic Metastases

University of Colorado Denver (CU Denver)

Status and phase: Terminated; Phase 4

Conditions: Oligometastatic Disease; Liver Metastases; Colorectal Cancer

Treatments: Drug: Gadobenate dimeglumine; Drug: Gadoxetate disodium

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT04973007

19-1045.cc

P30CA046934 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

If an abbreviated HBP protocol liver MR with gadobenate dimeglumine is shown clinically comparable to standard of care liver MR with gadoxetate disodium for detecting hepatic metastasis from colorectal cancer, its use will save time, cost, and patients' effort.

Full description

The goal is to:

• Estimate and compare the diagnostic performance, including sensitivity, specificity, positive/negative predictive value, and area under the receiver operating characteristics (AUROC), of abbreviated protocol liver magnetic resonance (MR) with hepatobiliary phase (HBP) using gadobenate dimeglumine for detecting liver metastases, with 1) abbreviated protocol liver MR with HBP using gadoxetate disodium, 2) standard of care complete protocol liver MR using gadoxetate disodium, and 3) complete protocol liver MR using gadobenate dimeglumine.
• Estimate and compare quantitative measures of HBP images (liver enhancement ratio, lesion contrast to noise and signal to noise ratios [CNR and SNR]) for both gadobenate dimeglumine and gadoxetate disodium.
• Qualitatively assess the preference, or lack thereof, of radiologists regarding the images generated by abbreviated protocol liver MR with HBP using gadobenate dimeglumine versus abbreviated protocol liver MR with HBP using gadoxetate disodium.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Colorectal cancer patients
• Age 18-80 years
• No prior treatment including surgery
• Prior imaging with suspected liver metastasis

Exclusion criteria

• Age < 18 years or > 80 years
• eGFR < 30 ml/min/1.73 m2
• Previous reaction to gadolinium contrast agents
• History of claustrophobia or movement disorders likely to impact image quality
• Non-MR safe implants or metallic foreign bodies

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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10 participants in 2 patient groups

Gadoxetate disodium exam first

Active Comparator group

Description:

The subjects will be randomized into two groups. Both groups will undergo two complete protocol liver MRs for known or suspected CRC metastasis, one exam with gadoxetate disodium and the other exam with gadobenate dimeglumine, within an interval of 3-10 days, but in opposite order, determined randomly.

Treatment:

Drug: Gadoxetate disodium

Drug: Gadobenate dimeglumine

Gadobenate Dimeglumine exam first

Active Comparator group

Description:

The subjects will be randomized into two groups. Both groups will undergo two complete protocol liver MRs for known or suspected CRC metastasis, one exam with gadoxetate disodium and the other exam with gadobenate dimeglumine, within an interval of 3-10 days, but in opposite order, determined randomly.

Treatment:

Drug: Gadoxetate disodium

Drug: Gadobenate dimeglumine