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Tests treatment safety and results for Known or Highly Suspected Central Nervous System (CNS)...
Official title A Phase 2/3 Study on the Efficacy and Safety of Mangaciclanol for Contrast-Enhanced MRI of CNS or Body in Adult Patients
ClinicalTrials.gov ID: NCT07472491
What this study is testing
What is Mangaciclanol, also known as GEH200486 Injection, 0.5 mmol/mL?
Mangaciclanol, also known as GEH200486 Injection, 0.5 mmol/mL is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for known or highly suspected central nervous system (cns) lesion.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an operationally combined Phase 2/3 study, which will be conducted and evaluated in 2 distinct parts: Phase 2: Prospective, adaptive, multicenter, non-randomized, single-blind, dose-finding, including participants with known or highly suspected lesions of the CNS. The aim of the Phase 2 part is to identify an optimized dose of mangaciclanol for the Phase 3 part of the study.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The participant is of legal majority age, as defined by local laws and regulations at the time of signing the ICF.
- The participant is able and willing to comply with study procedures as described in the protocol.
- The participant has read, understood, signed and dated the ICF prior to any study procedures.
- Phases 2 and 3 CNS: Participants presenting with known or highly suspected enhancing CNS lesions referred as part of standard care for...
- Phase 3 body only: Participants presenting with known or highly suspected enhancing lesions in at least 1 body region (i.e., head and neck, thorax...
You likely can't join if
- The participant has previously enrolled in this mangaciclanol study, including participation in an earlier phase or cohort.
- The participant has a contraindication to MRI examination, such as the presence of a cardiac pacemaker or other electronic devices, presence of...
- Participant with severe cardiovascular disease (e.g., known long QT syndrome including QTc prolongation based on screening ECG, acute myocardial...
- (Phase 2 only) Participant with an estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m2 calculated using the Chronic Kidney Disease...
- (Phase 3 only) Participant with an eGFR \<30 mL/min/1.73m2 calculated using the CKD-EPI within 14 days prior to the first IMP administration.
- Participant with increased likelihood of hypersensitivity specifically to mangaciclanol, gadolinium or a component of the formulation.
See the full eligibility criteria
- The participant is of legal majority age, as defined by local laws and regulations at the time of signing the ICF.
- The participant is able and willing to comply with study procedures as described in the protocol.
- The participant has read, understood, signed and dated the ICF prior to any study procedures.
- Phases 2 and 3 CNS: Participants presenting with known or highly suspected enhancing CNS lesions referred as part of standard care for contrast-enhancing MRI of the CNS. The suspicion may be based on a previous imaging...
- Phase 3 body only: Participants presenting with known or highly suspected enhancing lesions in at least 1 body region (i.e., head and neck, thorax, abdomen, pelvis, and musculoskeletal system [only breast in the United...
- The participant is scheduled for a contrast-enhanced MRI examination of the CNS or a body region for clinical reasons and has agreed to have a second contrast-enhanced MRI examination for the purpose of this study.
- The participant is in a clinically stable condition (i.e., no acute deterioration within 48 hours before enrollment).
- Female Participants: The participant is a female who is either surgically sterile (has had a documented bilateral oophorectomy, bilateral salpingectomy, and/or documented hysterectomy), postmenopausal (cessation of...
- Male Participants: The participant is a male who is surgically sterile (vasectomy or bilateral orchidectomy), a male who is sexually active with a partner who is not of childbearing potential, or a male who is sexually...
- The participant has previously enrolled in this mangaciclanol study, including participation in an earlier phase or cohort.
- The participant has a contraindication to MRI examination, such as the presence of a cardiac pacemaker or other electronic devices, presence of ferromagnetic metal foreign bodies in vulnerable positions or within...
- Participant with severe cardiovascular disease (e.g., known long QT syndrome including QTc prolongation based on screening ECG, acute myocardial infarction within the past 14 days, unstable angina, congestive heart...
- (Phase 2 only) Participant with an estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m2 calculated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) within 14 days prior to the...
- (Phase 3 only) Participant with an eGFR \<30 mL/min/1.73m2 calculated using the CKD-EPI within 14 days prior to the first IMP administration.
- Participant with increased likelihood of hypersensitivity specifically to mangaciclanol, gadolinium or a component of the formulation.
- Participant has received any non-study contrast agent within 72 hours prior to the first study MRI, or is planning to receive any non-study contrast agent during the trial until 24 ± 4 hours after the second study MRI.
- Participant has received any investigational product within 30 days or within 5 times the half-life of that drug, whichever is shorter, prior to or concurrent with this study.
- Participant is expected/scheduled to have any treatment or medical procedure (e.g., chemotherapy, radiotherapy, biopsy, resection, etc.) that may impact aspects of the imaged lesions from the first study MRI up to 24...
- Participant may not be able to complete the study, based on their anticipated life expectancy, or where study participation may compromise the management of the participant, or any other reason that in the judgment of...
- Participant is pregnant or planning to become pregnant, or breast-feeding.
- Participant is unable or unlikely to comply with the protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and/or considered unlikely to complete the trial.
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, Minnesota, United States
- The Woodlands, Texas, United States
- Tbilisi, Georgia
- Chisinau, Moldova
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, Minnesota, United States; The Woodlands, Texas, United States; Tbilisi, Georgia; Chisinau, Moldova; Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.