Prospective evaluation of potential effects of repeated gadoliniumbased contrast agent (GBCA) administrations of the same GBCA on motor and cognitive functions in neurologically normal adults in comparison to a non-GBCA exposed control group*ODYSSEY

Phase 4

• Conditions: motorische en cognitieve functie bij neurologisch normale volwassenen; Long term Impact of exposure to GBCA

• Registration Number: NL-OMON52180
• Lead Sponsor: IQvia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

1. Participant must be an adult having reached legal majority age and less than
65 years
old.
2. Participant must be neurologically normal, defined as free of unstable
neurologic and
psychiatric disease as confirmed by a normal neurologic examination at
screening.
3. Participant agrees to be tested as per protocol for 5 consecutive years
4. Participant (GBCA-exposed or controls) agrees to undergo UE-MRI of the brain
at
enrollment and at the end of the observation period (5 years).
5. Patient affiliated to national health insurance according to local regulatory
requirements, where applicable.
6. Participants should have at least 1 of the following indications:
• Medium to high risk for breast cancer or with dense breasts undergoing breast
cancer screening with MRI
• Elevated PSA under active diagnostic surveillance of prostate cancer
• Chronic liver disease (eg. liver cirrhosis limited to Child Class A,
post-hepatitis
chronic hepatopathy, or primary sclerosing cholangitis) for surveillance of
hepatocellular carcinoma development
• Low-grade colorectal cancer or neuroendocrine tumor undergoing surveillance
for
liver metastases
• Branch-duct intraductal papillary mucinous neoplasm (IPMN) of the pancreas
(maximum size <= 2 cm) undergoing imaging surveillance.

Exclusion Criteria

1. As evidenced by history or determined in the neurologic exam at screening,
concurrent
neurological and/or psychiatric disease (or treatments) that could influence
the results
of the study*s motor and cognitive tests. Examples include but are not limited
to:
• Cerebrovascular disease.
• Multiple sclerosis.
• Neurodegenerative disease.
• Malignant disease other than listed in indications.• Carcinoid tumors.
• Epilepsy.
• Prior neurosurgery.
• Psychotic disorders or any prior psychotic episode not otherwise specified
(NOS)*any documented prior history of chronic schizophrenia.
• Remittent or current medically confirmed major depressive disorder or bipolar
disorder. History of long-term major depression or bipolar affective disorder
with
an active episode in the past 2 to 5 years.
• Neurodevelopmental disorders (eg, trisomy 21).
• Uncontrolled severe migraine.
• Uncontrolled or controlled anxiety or depression within 6 months before
enrollment.
• Screening scores of <=24 on the MMSE and/or >=11 on the HADS.
2. Prior, planned, or ongoing chemotherapy or brain irradiation.
3. Use of concomitant medication(s) affecting neuro-cognitive or motor function
(an
authorized exception is a single intake before the study MRI because of anxiety
if
administered after the motor and cognitive test evaluation):
• Regular use of benzodiazepines or non-benzodiazepine hypnotics. Long-acting
benzodiazepines (eg, diazepam) should not be administered within 24 hours prior
to cognitive testing.
• Short/medium-acting benzodiazepines (eg, alprazolam, lorazepam, oxazepam,
temazepam), except if used chronically for sleep and on a stable dose for 8
weeks
prior to Screening Visit 1 or 12 hours prior to cognitive testing.
• Regular use of anticholinergic drugs (anticholinergics for bladder control
with
limited cognitive effects are permitted).
• Long-term use of corticosteroids or methotrexate, cladribine.
• Regular use of antidepressants (eg, anticholinergics, tricyclics, monoamine
oxidase
inhibitors [MAOIs], norepinephrine-dopamine reuptake inhibitors [NDRIs],
selective serotonin reuptake inhibitors [SSRIs], serotonin and norepinephrine
reuptake inhibitors [SNRIs], or lithium, anti-epileptics, and/or antipsychotic
drugs:
Use of antidepressants is allowed if at stable doses for 8 weeks prior to
Screening
Visit. Antipsychotics used on a regular basis, except for low doses of atypical
antipsychotics (e.g., risperidone, aripiprazole, or quetiapine),
anticonvulsants with
limited cognitive effects, such as lamotrigine, pregabalin, levetiracetam for
treatment of pain, and other non-epilepsy indications, are allowed as-needed
basis
or if used at a stable dose for 8 weeks prior to Screening Visit
• CNS stimulants (eg, for ADHD).
4. Substance or alcohol abuse as determined by the investigator.
5. Alcoholic cirrhosis.
6. Any history or presence of other relevant chronic disease that prevents
participation in
the study or that may confound neurofunction testing.
7. Renal disease, defined as estimated glomerular filtration rate (eGFR)
< 60 mL/min/1.73 m2, calculated by using the Modification of Diet in Renal
Disease
(MDRD) formula or the Kidney Disease Epidemiology Collaboration (CKD-EPI)
equation.
8. History of environmental/occupational/other exposure to one or mor

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified