NCT03070860

Brief Summary

The investigators hypothesize is that in PXE patients, low grade chronic inflammation could preceed the molecular and the clinical calcification process.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 6, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

June 28, 2018

Status Verified

June 1, 2018

Enrollment Period

1.1 years

First QC Date

June 13, 2016

Last Update Submit

June 27, 2018

Conditions

Pseudoxanthoma Elasticum

Keywords

Low Grade Chronic vascular and skin InflammationMolecular vascular and skin CalcificationCalcium Score

Outcome Measures

Primary Outcomes (2)

  • Vascular Inflammation

    Measurement 18F-FDG TBRs of patients with PXE; and the comparison of 18F-NaF femoral arteries' TBRs with popliteal artery's TBRs of patients with PXE (at 30 min and 90min post injection).

    90min post injection : 1 time

  • Molecular Calcification

    Measurement 18F-NaF femoral arteries' TBRs with popliteal artery's TBRs of patients with PXE

    90min post injection : 1 time

Study Arms (1)

PXE Patient

EXPERIMENTAL

positron emission tomography scanner (PET scan) 18-FDG and 18-NAF: conventionnal use.

Radiation: PET scan 18-FDG and 18-NAF

Interventions

PET scan 18-FDG and 18-NAFRADIATION

Positron emission tomography (PET) is a medical imaging test performed in a nuclear medicine department. PET scan is performed by IV injection of a mildly radioactive tracer (NAF and FDG).

Also known as: positron emission tomography
PXE Patient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • PXE patient diagnosed according the international criteria
  • Informed consent obtained
  • Patient affiliated to Health care system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Angers, 49933, France

Location

MeSH Terms

Conditions

Pseudoxanthoma ElasticumDermatitis

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Hemostatic DisordersVascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic DiseasesSkin AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, GeneticGenetic Diseases, InbornConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Loukman OMARJEE, MD,MSc

    University Hospital, Angers

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2016

First Posted

March 6, 2017

Study Start

November 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

June 28, 2018

Record last verified: 2018-06

Locations

FR(1)