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AzTrials

Lung Cancer Stage IVPhase 2GAPIMETNCT07492121

Screening for Brain Metastases

A Phase 2 study testing gadopiclenol (contrast agent) and standard contrast agent in people with Lung Cancer Stage IV and Melanoma Stage IV, run by University of Zurich at 1 site in Switzerland.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The survival of patients with CNS metastases often remains limited to some months. CNS metastases are also associated with neurological decline and decrease of quality of life. An early identification of CNS metastases may potentially lead to more therapeutic options and prevent or delay the development of… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
gadopiclenol (contrast agent) and standard contrast agent
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteSwitzerland
Study dates
Sep 2026to Jan 2030
Phase
Phase 2
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with histologically confirmed HER-2 positive or triple negative breast cancer, non-small cell lung cancer, or melanoma
  • Up to 3 months after diagnosis of a cancer at high risk of CNS metastasis with indication for screening and follow-up by MRI (based on a high risk of CNS metastases according to EANO ESMO brain metastases guidelines: stage IV HER-2 positive or triple negative breast, stage II to IV lung cancer, stage IV melanoma)
  • Enrolment at the time of initiation of screening and follow-up MRI: usually, but not necessarily at the time of new diagnosed stage IV HER-2 positive or triple negative breast, lung cancer, melanoma
  • 18 years or older on day of signing informed consent
  • Karnofsky performance status (KPS) ≥ 60
  • Patients must have preserved renal function (serum creatinine < 1.5 x ULN or creatinine clearance (CrCl) > 30 mL/min (using the Cockcroft-Gault formula)
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  • Women of child-bearing potential, including women who had their last menstruation in the last 2 years, must have a negative urinary or serum pregnancy test before the MRI.
  • Patients of childbearing / reproductive potential must agree to use adequate birth control measures, as defined by the investigator, during the study period and for at least 6 months after the last study treatment. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly.
  • Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and return for the required assessments.
  • Written informed consent for study participation must be signed and dated by the patient and the investigator prior to any study-related intervention.

Who cannot join

  • Any contraindication to MRI, including claustrophobia
  • Known severe adverse drug reaction or contraindication to gadolinium-based contrast agents
  • Acute or chronic renal insufficiency: grade III or more (eGFR <60 mL/min/1.73 m2) based on one eGFR assessment performed within one day the MRI prior to the first contrast agent injection.
  • Heart failure: class III/IV NYHA
  • Severe liver disease
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness that would limit compliance with study requirements
  • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
  • Women who are pregnant or who breast feeding

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Switzerland1 site

  • University Hospital Zurich

    Zurich, Canton of Zurich, 8091

    Nicolin Hainc, Dr, Nicolin.Hainc@usz.ch

    Emilie Le Rhun, Dr, GAPIMET@usz.ch

Other trials in Switzerland

About this study

Official title: Quality and Safety of Screening for Brain Metastases by Gadopiclenol in Patients With Cancer at High Risk of Developing Brain Metastases

The survival of patients with CNS metastases often remains limited to some months. CNS metastases are also associated with neurological decline and decrease of quality of life. An early identification of CNS metastases may potentially lead to more therapeutic options and prevent or delay the development of neurological symptoms and signs. Patients with cancer associated with a high risk of developing CNS metastasis will be enrolled in this trial. These patients are candidates for a screening brain MRI program in the routine management as recommended in current guidelines (Le Rhun et al. 2021) (Amaral et al. 2025, "ESMO Living Guideline: Cutaneous Melanoma, v1.0 February 2025").

The primary objective is to compare the time to CNS metastases diagnosis detected by MRI using different contrast agents (of gadopiclenol at a dose of 0.1 mmol/kg over current standard practice ) in patients with cancer considered at high risk of developing brain metastases.

Being tested
gadopiclenol (contrast agent), standard contrast agent
Keywords
screening MRI
Medical subject headings
Lung Neoplasms, Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • gadopiclenol (contrast agent)Other

    Also called elucirem

    Gadopiclenol is a contrast agent approved in Switzerland. In this study, a double-dose of gadopiclenol will be used: 0.2 mL body weight (equivalent to 0.1 mmol/kg BW) at the time of the screening brain MRI.

  • standard contrast agentOther

    as per local standard of care

Study groups in NCT07492121
Study groupRoleWhat they receive
gadopiclenol armActive comparatorNot described
Receives: Other: gadopiclenol (contrast agent)
standard contrast agent armExperimentalNot described
Receives: Other: standard contrast agent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time interval between enrolment and diagnosis of CNS metastases

    Measured: from randomization until diagnosis of CNS metastasis event or up to a maximum of 24 months

Secondary outcomes (7)

  1. Incidence of CNS metastases

    presence of brain metastases or leptomeningeal metastases

    Measured: from randomization until diagnosis of CNS metastasis event or up to a maximum of 24 months

  2. Assessment of the type of CNS metastases at the time of CNS event

    brain metastases, leptomeningeal metastases, both; and the number of measurable and non-measurable brain metastases

    Measured: from randomization until diagnosis of CNS metastasis event or up to a maximum of 24 months

  3. Description of the neurological assessment

    symptomatic versus asymptomatic; steroid consumption, Karnofsky performance status (KPS)

    Measured: from randomization until diagnosis of CNS metastasis event or up to a maximum of 24 months

  4. Assessment of the rate of diagnostic procedures triggered by the results and the rate of modifications of therapeutic decision making

    based on the pre-therapeutic imaging as compared to the diagnostic brain metastases imaging

    Measured: from randomization until diagnosis of CNS metastasis event or up to a maximum of 24 months

  5. Safety and tolerability 1

    adverse events (CTCAE v5.0)

    Measured: from randomization until one month after diagnosis of CNS metastasis event or up to a maximum of 25 months (one month after last MRI)

  6. Safety and tolerability 2

    short patient self-questionnaire on the tolerance of MRI

    Measured: from randomization until diagnosis of CNS metastasis event or up to a maximum of 24 months

  7. Qualitative assessment of images by the neuroradiologist

    overall visualization and characterization of the lesion; lesion border delineation; internal morphology; degree of contrast enhancement; technical image adequacy for diagnosis; diagnosis and confidence assigned to the diagnosis; overall diagnostic comfort

    Measured: from randomization until diagnosis of CNS metastasis event or up to a maximum of 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionJun 2029 (estimated)
  4. Study completionJan 2030 (estimated)

Resources

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 2
Primary purpose
Screening
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07492121
Sponsor's protocol ID
GAPIMET
Acronym
GAPIMET
Status last verified
Mar 2026
First submitted
25 Sep 2025
Last updated
25 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Le Rhun E, Guckenberger M, Smits M, Dummer R, Bachelot T, Sahm F, Galldiks N, de Azambuja E, Berghoff AS, Metellus P, Peters S, Hong YK, Winkler F, Schadendorf D, van den Bent M, Seoane J, Stahel R, Minniti G, Wesseling P, Weller M, Preusser M; EANO Executive Board and ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. EANO-ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up of patients with brain metastasis from solid tumours. Ann Oncol. 2021 Nov;32(11):1332-1347. doi: 10.1016/j.annonc.2021.07.016. Epub 2021 Aug 6. No abstract available.

    PubMed 34364998

  • Bendszus M, Roberts D, Kolumban B, Meza JA, Bereczki D, San-Juan D, Liu BP, Anzalone N, Maravilla K. Dose Finding Study of Gadopiclenol, a New Macrocyclic Contrast Agent, in MRI of Central Nervous System. Invest Radiol. 2020 Mar;55(3):129-137. doi: 10.1097/RLI.0000000000000624.

    PubMed 31917762

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing gadopiclenol (contrast agent) and standard contrast agent in people with Lung Cancer Stage IV and Melanoma Stage IV, run by University of Zurich at 1 site in Switzerland.

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 10 inclusion and 8 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: opening soon, as of the sponsor's last update on 25 Mar 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 Switzerland. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time interval between enrolment and diagnosis of CNS metastases (time frame: from randomization until diagnosis of CNS metastasis event or up to a maximum of 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07492121, which also lists 2 linked publications.

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 25 Mar 2026; AzTrials last refreshed its copy on 28 Oct 2026.

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