Assessment of Cardiac Fixation During PET Using a New Drug Within Amyloid Cardiac Injuries.

NCT03232632 | Terminated Early Phase 1

• 1 other identifier: 13 199 02
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

To estimate distribution's parameters of 18F-Flutemetamol (Vizamyl®) fixation on myocardium for patients with amyloid cardiac injuries.

Conditions

Cardiac Amyloidosis

Outcome Measures

Primary Outcomes (2)

• ratio Heart/ Upper Mediastinum

  peak of 18F-Flutemetamol capture

  average of last 15 minutes

• standardized uptake value (SUV) measures

  standardized uptake value (SUV) measures

  average of last 15 minutes

Study Arms (1)

PET with 18 F-Flutemetamol

EXPERIMENTAL

PET with 18 F-Flutemetamol (Vizamyl®) = product under Alzheimer's disease indication

Drug: PET with 18 F-Flutemetamol

Interventions

PET with 18 F-Flutemetamol DRUG

PET with 18 F-Flutemetamol (Vizamyl ®)

Also known as: Vizamyl®

PET with 18 F-Flutemetamol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients followed for amyloidosis with proved cardiac injury or strongly suspected:
• cardiac echography with typical signs of amyloid injury,
• anatomical result confirming presence of amyloid deposits at cardiac or peripheral level
• Signature of Informed Consent Form,
• Affiliation to a social security system

You may not qualify if:

• Patient who suffers from another pathology which could lead cardiac injury (coronary disease, valvular disease, other pathology of deposit),
• Pregnancy and lactating women,
• Absence of effective contraception,
• Irradiating examination performed within the last 12 months or scheduled within the next 12 months,
• Unable patient physically, mentally or legally to provide informed consent,
• Patient under a system of legal protection

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital Toulouse

Toulouse, 31000, France

Location

MeSH Terms

Conditions

Amyloid Neuropathies, Familial

Interventions

2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole; flutemetamol

Condition Hierarchy (Ancestors)

Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Amyloidosis; Proteostasis Deficiencies

Study Officials

• Eric OUHAYOUN, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2017
• First Posted: July 28, 2017
• Study Start: March 15, 2017
• Primary Completion: September 15, 2019
• Study Completion: September 15, 2019
• Last Updated: August 26, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)