--- title: P03277 Dose Finding Study in Central Nervous System (CNS) Magnetic Resonance Imaging (MRI) nct_id: NCT02633501 overall_status: COMPLETED phase: PHASE2 sponsor: Guerbet study_type: INTERVENTIONAL primary_condition: CNS Lesion countries: United States, Belgium, Czechia, Hungary, Italy, Mexico, Poland, South Korea canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02633501.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02633501" ct_last_update_post_date: 2021-10-25 last_seen_at: "2026-05-12T06:29:13.985Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # P03277 Dose Finding Study in Central Nervous System (CNS) Magnetic Resonance Imaging (MRI) **NCT ID:** [NCT02633501](https://clinicaltrials.gov/study/NCT02633501) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE2 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 312 - **Lead Sponsor:** Guerbet - **Conditions:** CNS Lesion, Blood Brain Barrier Defect - **Start Date:** 2016-06 - **Completion Date:** 2018-01 - **CT.gov Last Update:** 2021-10-25 ## Brief Summary The purpose of this study was to determine a safe and effective dose of a new gadolinium-based contrast agent (GBCA) P03277 based on the Contrast to Noise Ratio (CNR) when comparing with gadobenate dimeglumine (MultiHance®) at 0.1 mmol/kg body weight (BW). Contrast to Noise Ratio (CNR), a well-known quantitative parameter directly related to contrast medium/GBCA efficacy, was chosen as the primary endpoint in order to have a precise determination of P03277 clinical dose. This was a multi-center, international, prospective, double-blind, randomized, controlled, parallel dose groups, cross-over with comparator study in male and female subjects presenting with known or highly suspected focal areas of disruption of the Blood Brain Barrier including at least one expected enhancing lesion of minimum 5 mm, who were scheduled to undergo a routine contrast-enhanced Magnetic Resonance Imaging (MRI) of Central Nervous System. ## Detailed Description Two subsets of subjects were included in the study: * The subset 1 included the first randomized subject of each study center. Subjects were randomly assigned in a 1:1 ratio to receive 0.05 or 0.1 mmol/kg BW of P03277 and 0.1 mmol/kg BW of gadobenate dimeglumine. * Subset 2 was composed of all subjects (except the first one of each study center) selected by the study center. Subjects were randomly assigned in a 1:1:1:1 ratio to receive 0.025, 0.05, 0.1 or 0.2 mmol/kg BW of P03277 and 0.1 mmol/kg BW of gadobenate dimeglumine. During the course of the study, two MRIs were obtained from each subject: one unenhanced and P03277-enhanced MRI; and one unenhanced and gadobenate dimeglumine-enhanced MRI. MRI images were evaluated off-site by 3 independent blinded readers for the primary endpoint (CNR). ## Eligibility - **Minimum age:** 18 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion Criteria: * Female or male adult subjects, with known or highly suspected focal areas of disrupted Blood Brain Barrier including at least one expected enhancing lesion of minimum 5 mm (long axis). This lesion had been detected on a previous imaging procedure (computerized Tomography \[CT\] or MRI). * Subject scheduled for a routine contrast-enhanced MRI examination of Central Nervous System for clinical reasons and agreeing to have a second contrast-enhanced MRI examination for the purpose of the study. Exclusion Criteria: * Subject presenting with acute or chronic Grade III (at least) renal insufficiency, defined as an estimated Glomerular Filtration Rate (eGFR) \<60 mL/min/1.73 m² based on one eGFR assessment performed the day of the MRI prior to the first contrast agent injection. ``` ## Arms - **Subset 1 Arm 1** (EXPERIMENTAL) — One of the two doses of P03277 (0.05 or 0.1 mmol/kg)-enhanced MRI then gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI - **Subset 1 Arm 2** (EXPERIMENTAL) — Gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI then one of the two doses of P03277 (0.05 or 0.1 mmol/kg)-enhanced MRI - **Subset 2 Arm 1** (EXPERIMENTAL) — One of the four doses of P03277 (0.025, 0.05, 0.1 or 0.2 mmol/kg)-enhanced MRI then gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI - **Subset 2 Arm 2** (EXPERIMENTAL) — Gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI then one of the four doses of P03277 (0.025, 0.05, 0.1 or 0.2 mmol/kg)-enhanced MRI ## Interventions - **P03277** (DRUG) — Single intravenous (IV) bolus injection at a rate of 2 mL/second - **Gadobenate dimeglumine** (DRUG) — Single IV bolus injection at a rate of 2 mL/second - **MRI** (DEVICE) ## Primary Outcomes - **Contrast to Noise Ratio (CNR) Difference** _(time frame: 1 day procedure)_ — The Contrast-to-Noise Ratio (CNR) was calculated from the signal intensity measurement of maximum 3 enhanced lesions by 3 independent blinded readers. Only lesions detected by both MRIs after lesion tracking were used. The difference in CNR was calculated as follow: CNR (P03277) - CNR (gadobenate dimeglumine). ## Locations (28) - Northwestern memorial hospital, Chicago, Illinois, United States - Beth israel deaconess medical center, Boston, Massachusetts, United States - QUEST Research Institute, Farmington Hills, Michigan, United States - Penn State milton S. Hershey Medical center, Hershey, Pennsylvania, United States - University of Pensylvania medical center, Philadelphia, Pennsylvania, United States - Temple university hospital, Philadelphia, Pennsylvania, United States - Rhode Island hospital, Providence, Rhode Island, United States - Medical University of South Carolina, Charleston, South Carolina, United States - University of texas McGovern medical school, Houston, Texas, United States - University of Washington, Seattle, Washington, United States - ZNA campus Middelheim, Antwerp, Belgium - Universitair Ziekenhuis Brussel, Brussels, Belgium - Fakultni nemocnice Olomouc, Olomouc, Czechia - Neurology Clinic-Semmelweis Medical University, Budapest, Hungary - Pecsi Tudomany Egyetem Klinikai kozpont Idegsebeszeti Klinica, Pécs, Hungary - Ospedali Riuniti di Ancona, Ancona, Italy - Ospedale san Raffaele, Milan, Italy - AO S. Andrea Universita La Sapienza, Roma, Italy - Azienda policlinico Umberto, Roma, Italy - Centro medico ABC santa fe, Mexico City, Mexico - Axis heilsa, Monterrey, Mexico - Clinical research institute SC, Tlalnepantla, Mexico - Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie, Oddzial w Gliwicach, Gliwice, Poland - krakowski Szpital specjalistyczny il Jana Pawla II, Krakow, Poland - Samodzielny publiczny szpital, Lublin, Poland - Asan medical center, Seoul, South Korea - Samsung medical center, Seoul, South Korea - Seoul National university hospital, Seoul, South Korea ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `locations.rhode island hospital|providence|rhode island|united states` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.northwestern memorial hospital|chicago|illinois|united states` — added _(2026-05-12)_ - `locations.beth israel deaconess medical center|boston|massachusetts|united states` — added _(2026-05-12)_ - `locations.quest research institute|farmington hills|michigan|united states` — added _(2026-05-12)_ - `locations.penn state milton s. hershey medical center|hershey|pennsylvania|united states` — added _(2026-05-12)_ - `locations.university of pensylvania medical center|philadelphia|pennsylvania|united states` — added _(2026-05-12)_ - `locations.temple university hospital|philadelphia|pennsylvania|united states` — added _(2026-05-12)_ - `locations.medical university of south carolina|charleston|south carolina|united states` — added _(2026-05-12)_ - `locations.university of texas mcgovern medical school|houston|texas|united states` — added _(2026-05-12)_ - `locations.university of washington|seattle|washington|united states` — added _(2026-05-12)_ - `locations.zna campus middelheim|antwerp||belgium` — added _(2026-05-12)_ - `locations.universitair ziekenhuis brussel|brussels||belgium` — added _(2026-05-12)_ - `locations.fakultni nemocnice olomouc|olomouc||czechia` — added _(2026-05-12)_ - `locations.neurology clinic-semmelweis medical university|budapest||hungary` — added _(2026-05-12)_ - `locations.pecsi tudomany egyetem klinikai kozpont idegsebeszeti klinica|pécs||hungary` — added _(2026-05-12)_ - `locations.ospedali riuniti di ancona|ancona||italy` — added _(2026-05-12)_ - `locations.ospedale san raffaele|milan||italy` — added _(2026-05-12)_ - `locations.ao s. andrea universita la sapienza|roma||italy` — added _(2026-05-12)_ - `locations.azienda policlinico umberto|roma||italy` — added _(2026-05-12)_ - `locations.centro medico abc santa fe|mexico city||mexico` — added _(2026-05-12)_ - `locations.axis heilsa|monterrey||mexico` — added _(2026-05-12)_ - `locations.clinical research institute sc|tlalnepantla||mexico` — added _(2026-05-12)_ - `locations.centrum onkologii instytut im. marii sklodowskiej-curie, oddzial w gliwicach|gliwice||poland` — added _(2026-05-12)_ - `locations.krakowski szpital specjalistyczny il jana pawla ii|krakow||poland` — added _(2026-05-12)_ - `locations.samodzielny publiczny szpital|lublin||poland` — added _(2026-05-12)_ - `locations.asan medical center|seoul||south korea` — added _(2026-05-12)_ - `locations.samsung medical center|seoul||south korea` — added _(2026-05-12)_ - `locations.seoul national university hospital|seoul||south korea` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT02633501.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT02633501* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*