Contrast Enhanced Images vs. Non-contrast ImagesPhase 4MRINCT06846853
Gadopiclenol vs. Gadobutrol for Dynamic Contrast-Enhanced Pituitary MRI (Magnetic Resonance Imaging)
A Phase 4 study testing Gadopiclenol and Gadobutrol (Gadavist, BAY86-4875) in people with Contrast Enhanced Images vs. Non-contrast Images and Gadopiclinol Enhanced Images vs. Gadobutrol Enhanced Images, run by UConn Health at 1 site in United States.
Trial summary
This study will evaluate the efficacy and safety of Gadopiclenol, an FDA-approved contrast agent, for visualizing pituitary lesions on MR images by comparing with the comparator, Gadobutrol, a clinically widely used contrast agent. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Contrast Enhanced Images vs. Non-contrast Images, Gadopiclinol Enhanced Images vs. Gadobutrol Enhanced Images
- What is being tested?
- Gadopiclenol and Gadobutrol (Gadavist, BAY86-4875)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2025to 30 Jun 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male adult patient who is at 18 years old or above, or female adult patient who is at 55 years old or above.
- Patient presenting with known or highly suspected pituitary lesion(s) with focal areas of disrupted Blood Brain Barrier (BBB) (e.g., primary and secondary tumors) based on results of a previous imaging procedure such as Computed Tomography (CT) or MRI, which should have been performed within 12 months prior to informed consent form signature.
- Patient scheduled for a contrast-enhanced MRI examination with a focus on pituitary for clinical reasons and agreeing to have a second contrast-enhanced MRI examination for the purpose of the trial.
- If the patient was treated (either with radiation, surgery, biopsy or other relevant treatments) for a pituitary condition between previous imaging evaluation and trial MRI, there should still be a high suspicion of remaining lesion(s) on the basis of available clinical information.
- Patient able and willing to participate in the trial.
- Patient having read the information and having provided his/her consent to participate in writing by dating and signing the informed consent prior to any trial related procedure being conducted.
- Patient affiliated to national health insurance according to local regulatory requirements.
Who cannot join
- Patient presenting with known class III/IV congestive heart failure according to the New York Heart Association classification (NYHA).
- Patient having received any investigational medicinal product within 7 days prior to trial entry or scheduled to receive any investigational treatment in the course of the trial.
- Patient presenting with any contraindication to MRI examinations.
- Patient previously randomized in this trial.
- Patient having received any contrast agent (MRI or CT) within 3 days prior to first trial product administration, or scheduled to receive any contrast agent during the course of the trial or within 24 hours after the second trial product administration
- Patient expected/scheduled to have any treatment or medical procedure (e.g. chemotherapy, radiotherapy, biopsy or surgery etc.) that may impact the aspects of the imaged lesions between the 2 MRI examinations. (Patients under corticosteroids and/or maintenance chemotherapy with a stable dose at the time of screening visit and throughout the trial can be included).
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- Patient with anticipated, current or past condition (medical, psychological, social or geographical) that would compromise the patient's safety or her/his ability to participate in the trial.
- 8. Patient unlikely to comply with the protocol, e.g. uncooperative attitude, inability to return for follow-up visits and/or unlikelihood of completing the trial.
- 9. Patient related to the investigator or any other trial staff or relative directly involved in the trial conduct. 10. Patient presenting with acute or chronic renal insufficiency, defined as an estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73 m² assessed within 1 day prior to each contrast agent injection. 11. Patient with known contra-indication(s) to the use or with known sensitivity to one of the products under investigation or to other GBCAs (such as hypersensitivity, post contrast acute kidney injury).
- 12. Patient who are prisoners, pregnant women, or educationally disadvantaged persons known as vulnerable population will be excluded as well to protect the rights and welfare of these participants.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Connecticut Health Center
Farmington, Connecticut, 06030
About this study
Official title: Gadopiclenol vs. Gadobutrol for Dynamic Contrast-Enhanced Pituitary MRI: A Pilot Study
This study will evaluate the efficacy and safety of Gadopiclenol, an FDA-approved contrast agent, for visualizing pituitary lesions on MR images by comparing with the comparator, Gadobutrol, a clinically widely used contrast agent. The study is double-blinded, so neither the participants nor the researchers know which contrast agent is being used during each scan to avoid the bias of results.
Read the detailed description
Gadopiclenol (brand name Elucirem), initially invented by Guerbet, is an FDA-approved macrocyclic gadolinium-based contrast agent (GBCA) with high relaxivity and high kinetic stability. The higher relaxivity allows for a lower dose of gadopiclenol, reducing the total amount of gadolinium administration (hence reducing the toxicity of gadolinium) while preserving imaging quality.
Gadopiclenol was approved by the FDA with a recommended dose of 0.05 mmol/kg for adults and pediatric patients aged 2 years and older. The PICTURE Trial demonstrated that Gadopiclenol at 0.05 mmol/kg which is half dose of standard macrocyclic GBCAs (Gadobutrol at 0.1 mmol/kg) revealed noninferiority for contrast-enhancing intracranial lesions against the background of nonenhancing brain.
A pituitary microadenoma or a Rathke's cyst is typically demonstrated on MRI by virtue of hypoenhancement of the lesion against the background of the hyperenhancing pituitary. Dynamic pituitary imaging with Gadopiclenol has not been investigated so far.
This pilot study will assess the value of Gadopiclenol at 0.05 mmol/kg vs. Gadobutrol 0.1 mmol/kg as a contrast agent for MRI in the evaluation of pituitary lesions. We hypothesize that there will be a trend that Gadopiclenol will increase the enhancement of the background pituitary gland to a similar degree. The safety data utilizing Gadopiclenol will also be evaluated. We anticipate comparable safety of 0.05 mmol/kg of Gadopiclenol and 0.1 mmol/kg Gadobutrol.
- Conditions
- Contrast Enhanced Images vs. Non-contrast Images, Gadopiclinol Enhanced Images vs. Gadobutrol Enhanced Images
- Being tested
- Gadopiclenol, Gadobutrol (Gadavist, BAY86-4875)
- Keywords
- Gadobutrol enhanced images, Gadopiclinol enhanced images
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GadopiclenolDrug
The enhanced images by Gadopiclenol and Gadobutrol will be compared.
Gadobutrol (Gadavist, BAY86-4875)Drug
Gadobutrol will be used as a comparator
| Study group | Role | What they receive |
|---|---|---|
| Gadopiclinol (brand name, Elucirem) first group | Experimental | Participants of Arm 1 will use Gadopiclinol (Brand name, Elucirem) contrast for the first MRI scan and use Gadobutrol (Brand name, Gadavist)contrast for the second MRI scan Receives: Drug: Gadopiclenol |
| Gadobutrol (Brand name, Gadavist) first group | Active comparator | Participants of Arm 2 will use Gadobutrol contrast for the MRI scan and Gadopiclinol contrast for the second MRI scan. Receives: Drug: Gadobutrol (Gadavist, BAY86-4875) |
What is being measured
The primary outcome is the main question the study is designed to answer.
hypointense for lesions with respect to pituitary
The primary outcome measures will include both subjective assessments and an objective measure.
The subjective assessments will include part 1) the lesion intensity of the pituitary either having: a) Not Hypointense; b) Mildly Hypointense; c) Markedly Hypointense and part 2) the overall diagnostic quality of the contrast vs noncontrast and of the two contrast agent ( Godopiclinol vs. Godobutrol) side by side as: a) Prefer 1; b) No difference; c) Prefer 2.
The objective measure is the Contrast/Noise intensity of the pituitary:
[Signal Intensity Background Pituitary - Signal Intensity Lesion] / Signal Intensity Air
Measured: Two MRI scans will be conducted separated by 3-14 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start25 Mar 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contrast Enhanced Images vs. Non-contrast ImagesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a double-blinded cross-over study. Study participants will be assigned randomly to have either Gadopiclenol or Gadobutrol contrast for the first MRI scan and followed by the other contract for the second MRI scan 3-14 days later.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leo Wolansky, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06846853
- Sponsor's protocol ID
- 25-175-1
- Acronym
- MRI
- Status last verified
- Apr 2025
- First submitted
- 20 Feb 2025
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gadopiclenol vs. Gadobutrol for Dynamic Contrast-Enhanced Pituitary MRI: A Pilot Study
- ClinicalTrials.gov ID
- NCT06846853
- Acronym / sponsor ID
- MRI / 25-175-1
- Conditions
- Contrast Enhanced Images vs. Non-contrast Images, Gadopiclinol Enhanced Images vs. Gadobutrol Enhanced Images
- Keywords
- Gadobutrol enhanced images, Gadopiclinol enhanced images
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 26 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the efficacy and safety of Gadopiclenol, an FDA-approved contrast agent, for visualizing pituitary lesions on MR images by comparing with the comparator, Gadobutrol, a clinically widely used contrast agent. The study is double-blinded, so neither the participants nor the researchers know which contrast agent is being used during each scan to avoid the bias of results.
Detailed description
Gadopiclenol (brand name Elucirem), initially invented by Guerbet, is an FDA-approved macrocyclic gadolinium-based contrast agent (GBCA) with high relaxivity and high kinetic stability. The higher relaxivity allows for a lower dose of gadopiclenol, reducing the total amount of gadolinium administration (hence reducing the toxicity of gadolinium) while preserving imaging quality.
Gadopiclenol was approved by the FDA with a recommended dose of 0.05 mmol/kg for adults and pediatric patients aged 2 years and older. The PICTURE Trial demonstrated that Gadopiclenol at 0.05 mmol/kg which is half dose of standard macrocyclic GBCAs (Gadobutrol at 0.1 mmol/kg) revealed noninferiority for contrast-enhancing intracranial lesions against the background of nonenhancing brain.
A pituitary microadenoma or a Rathke's cyst is typically demonstrated on MRI by virtue of hypoenhancement of the lesion against the background of the hyperenhancing pituitary. Dynamic pituitary imaging with Gadopiclenol has not been investigated so far.
This pilot study will assess the value of Gadopiclenol at 0.05 mmol/kg vs. Gadobutrol 0.1 mmol/kg as a contrast agent for MRI in the evaluation of pituitary lesions. We hypothesize that there will be a trend that Gadopiclenol will increase the enhancement of the background pituitary gland to a similar degree. The safety data utilizing Gadopiclenol will also be evaluated. We anticipate comparable safety of 0.05 mmol/kg of Gadopiclenol and 0.1 mmol/kg Gadobutrol.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a double-blinded cross-over study. Study participants will be assigned randomly to have either Gadopiclenol or Gadobutrol contrast for the first MRI scan and followed by the other contract for the second MRI scan 3-14 days later.
| Arm | Type | Receives |
|---|---|---|
| Gadopiclinol (brand name, Elucirem) first group | Experimental | Drug: GadopiclenolParticipants of Arm 1 will use Gadopiclinol (Brand name, Elucirem) contrast for the first MRI scan and use Gadobutrol (Brand name, Gadavist)contrast for the second MRI scan |
| Gadobutrol (Brand name, Gadavist) first group | Active comparator | Drug: Gadobutrol (Gadavist, BAY86-4875)Participants of Arm 2 will use Gadobutrol contrast for the MRI scan and Gadopiclinol contrast for the second MRI scan. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male adult patient who is at 18 years old or above, or female adult patient who is at 55 years old or above.
- Patient presenting with known or highly suspected pituitary lesion(s) with focal areas of disrupted Blood Brain Barrier (BBB) (e.g., primary and secondary tumors) based on results of a previous imaging procedure such as Computed Tomography (CT) or MRI, which should have been performed within 12 months prior to informed consent form signature.
- Patient scheduled for a contrast-enhanced MRI examination with a focus on pituitary for clinical reasons and agreeing to have a second contrast-enhanced MRI examination for the purpose of the trial.
- If the patient was treated (either with radiation, surgery, biopsy or other relevant treatments) for a pituitary condition between previous imaging evaluation and trial MRI, there should still be a high suspicion of remaining lesion(s) on the basis of available clinical information.
- Patient able and willing to participate in the trial.
Key exclusion criteria (10 listed)
- Patient presenting with known class III/IV congestive heart failure according to the New York Heart Association classification (NYHA).
- Patient having received any investigational medicinal product within 7 days prior to trial entry or scheduled to receive any investigational treatment in the course of the trial.
- Patient presenting with any contraindication to MRI examinations.
- Patient previously randomized in this trial.
- Patient having received any contrast agent (MRI or CT) within 3 days prior to first trial product administration, or scheduled to receive any contrast agent during the course of the trial or within 24 hours after the second trial product administration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GadopiclenolThe enhanced images by Gadopiclenol and Gadobutrol will be compared. | Drug | Gadopiclinol (brand name, Elucirem) first group |
| Gadobutrol (Gadavist, BAY86-4875)Gadobutrol will be used as a comparator | Drug | Gadobutrol (Brand name, Gadavist) first group |
Primary outcome
hypointense for lesions with respect to pituitary
Time frame: Two MRI scans will be conducted separated by 3-14 days.
The primary outcome measures will include both subjective assessments and an objective measure. The subjective assessments will include part 1) the lesion intensity of the pituitary either having: a) Not Hypointense; b) Mildly Hypointense; c) Markedly Hypointense and part 2) the overall diagnostic quality of the contrast vs noncontrast and of the two contrast agent ( Godopiclinol vs. Godobutrol) side by side as: a) Prefer 1; b) No difference; c) Prefer 2. The objective measure is the Contrast/Noise intensity of the pituitary: [Signal Intensity Background Pituitary - Signal Intensity Lesion] / Signal Intensity Air
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- This study aimed to demonstrate that contrast-enhanced MRI of the central nervous system (CNS) with gadopiclenol at 0.05 mmol/kg is not inferior to gadobutrol at 0.1 mmol/kg, and superior to unenhanced MRI. The results supported the hypothesis.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gadopiclenol and Gadobutrol (Gadavist, BAY86-4875) in people with Contrast Enhanced Images vs. Non-contrast Images and Gadopiclinol Enhanced Images vs. Gadobutrol Enhanced Images, run by UConn Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lihong Wang, MD, Ph D (860-679-7881, lwang@uchc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hypointense for lesions with respect to pituitary (time frame: Two MRI scans will be conducted separated by 3-14 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.