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Contrast Agent

Contrast Agents for Detecting Liver Metastases

Phase 4
Recruiting
Led By Samuel Chang, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18-80 years
No prior treatment including surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month
Awards & highlights

Study Summary

This trial showed that an abbreviated HBP protocol liver MRI with gadobenate dimeglumine is just as effective as the standard liver MRI with gadoxetate disodium for detecting hepatic metastasis from colorectal cancer.

Who is the study for?
This trial is for adults aged 18-80 with colorectal cancer who have suspected liver metastases and haven't had any treatments, including surgery. It's not suitable for those with poor kidney function, non-MR safe implants, a history of bad reactions to gadolinium contrast agents, claustrophobia or movement disorders.Check my eligibility
What is being tested?
The study compares two MRI contrast agents: Gadoxetate disodium (standard care) versus Gadobenate dimeglumine (potential time and cost saver). The goal is to see if the latter can detect liver metastases from colorectal cancer as effectively as the former.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to the contrast agent such as itching or rash, headache, nausea, dizziness, or a feeling of warmth or cold at the injection site. Kidney issues are also possible but less likely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 80 years old.
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I have not had any treatment, including surgery, for my condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Diagnostic Performance of gadobenate dimeglumine
Preference of radiologists for the images generated by amHBP versus aeHBP
Quantitative Measures of hepatobiliary phase images
Secondary outcome measures
Compare Cost Associated with Imaging Method
Compare Patient Time Associated with Imaging Method
Compare Sensitivity and Specificity
+1 more

Trial Design

2Treatment groups
Active Control
Group I: Gadoxetate disodium exam firstActive Control2 Interventions
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.
Group II: Gadobenate Dimeglumine exam firstActive Control2 Interventions
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.

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,737 Previous Clinical Trials
2,149,251 Total Patients Enrolled
Bracco Diagnostics, IncIndustry Sponsor
60 Previous Clinical Trials
11,308 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,664 Previous Clinical Trials
40,925,950 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any more participants being recruited to join this research project?

"Affirmative. Information available on clinicaltrials.gov states that this experiment is actively seeking participants, with 55 individuals needing to be recruited from a single medical centre. The trial was first posted June 22nd 2021 and has most recently been updated October 18th 2022."

Answered by AI

What medical conditions is Gadobenate Dimeglumine primarily employed to address?

"The initial treatment method for ailments such as magnetic resonance angiography, veno-occlusive disease, and chronic liver diseases (cld) should be a Gadobenate Dimeglumine exam."

Answered by AI

What safety measures have been taken to ensure Gadobenate Dimeglumine is safe for use?

"The safety of Gadobenate Dimeglumine exam first has been rated as a 3 by Power, reflecting its Phase 4 status which confirms it is approved for medical use."

Answered by AI

What is the ultimate goal of this medical experiment?

"Bracco Diagnostics, Inc., the trial sponsor, has identified quantitative measures of hepatobiliary phase images as their primary outcome. This result will be observed over a one-month duration. Secondary outcomes include comparison in sensitivity and specificity when pathology is unavailable; testing the validity of imaging methods; and comparisons on patient time associated with the imaging method."

Answered by AI

How many participants have joined this research endeavor?

"Affirmative. Information posted on clinicaltrials.gov states that recruitment for this medical trial is still in progress, beginning June 22nd 2021 and most recently updated October 18th 2022. 55 patients are sought to be enrolled at a single site of study."

Answered by AI

Has Gadobenate Dimeglumine been previously scrutinized through a clinical trial process?

"Currently, 5 clinical trials related to Gadobenate Dimeglumine exam first are operational with 0 studies in the final phase. 36 medical sites across the country have been designated as trial locations, with most of them situated in Aurora, Colorado."

Answered by AI
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~4 spots leftby Aug 2024