NCT01916057

Brief Summary

The purpose of this study is to determine whether F18 fluorodeoxyglucose (18F-FDG) positron-emission tomography scan (PET scan) is useful for the therapy strategy of hepatosplenic candidiasis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2013

Longer than P75 for not_applicable

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

August 2, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 5, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

November 19, 2013

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2018

Completed
Last Updated

September 8, 2025

Status Verified

September 1, 2025

Enrollment Period

3.5 years

First QC Date

August 2, 2013

Last Update Submit

September 1, 2025

Conditions

Invasive Fungal DiseaseChronic Disseminated CandidiasisHematological MalignanciesHematopoietic Stem Cell TransplantationNeutropenia

Keywords

Positron-Emission Tomography ScanFluorodeoxyglucose F18Magnetic Resonance ImagingEnzyme-Linked Immunospot AssayImmune Reconstitution Inflammatory SyndromeReal-Time Polymerase Chain Reactionbeta-1,3-D-glucanCandida spp.Genetic SusceptibilityGenotype

Outcome Measures

Primary Outcomes (1)

  • Global response to therapy

    Clinical assessment (no fever) and PET scan assessment (intensity of liver and/or spleen lesions)

    at month 3

Secondary Outcomes (8)

  • 18F-FDG PET scan and RMI usefulness in initial diagnosis

    at month 3

  • Serological and molecular mycological tools assessment

    at day 0

  • Serological and molecular mycological tools assessment

    at Month 3

  • Serological and molecular mycological tools assessment

    at Month 6

  • Inflammatory cells and mediators

    at day 0

  • +3 more secondary outcomes

Study Arms (1)

18F-FDG PET Scan

EXPERIMENTAL

18F-FDG PET Scan at Day 0 and M3

Device: 18F-FDG PET Scan

Interventions

18F-FDG PET ScanDEVICE

to determine whether F18 fluorodeoxyglucose (18F-FDG) positron-emission tomography scan (PET scan) is useful for the therapy strategy of hepatosplenic candidiasis.

18F-FDG PET Scan

Eligibility Criteria

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

You may qualify if:

  • Adults aged ≥18 years-old
  • Hospitalized for hematological malignancy or hematopoietic stem cell transplantation
  • Recent (\>2months), prolonged (\>10 days), profound (\>100 PMN/mm3), feverish neutropenia
  • Suspected hepatosplenic candidiasis (typical small nodular lesions on abdominal RMI or CT)

You may not qualify if:

  • \- hepatosplenic lesions of other proven origin
  • Life expectancy \>3 months
  • Pregnancy
  • HIV infection
  • Hepatic biopsy within 3 weeks before 18F-FDG PET scan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service des Maladies Infectieuses et Tropicales - Centre d'Infectiologie Necker-Pasteur, IHU Imagine - Hôpital Necker-Enfants Malades,

Paris, 75015, France

Location

Related Publications (2)

  • Rammaert B, Maunoury C, Rabeony T, Correas JM, Elie C, Alfandari S, Berger P, Rubio MT, Braun T, Bakouboula P, Candon S, Montravers F, Lortholary O. Does 18F-FDG PET/CT add value to conventional imaging in clinical assessment of chronic disseminated candidiasis? Front Med (Lausanne). 2022 Dec 20;9:1026067. doi: 10.3389/fmed.2022.1026067. eCollection 2022.

    PMID: 36606049BACKGROUND

  • Candon S, Rammaert B, Foray AP, Moreira B, Gallego Hernanz MP, Chatenoud L, Lortholary O. Chronic Disseminated Candidiasis During Hematological Malignancies: An Immune Reconstitution Inflammatory Syndrome With Expansion of Pathogen-Specific T Helper Type 1 Cells. J Infect Dis. 2020 May 11;221(11):1907-1916. doi: 10.1093/infdis/jiz688.

    PMID: 31879764BACKGROUND

MeSH Terms

Conditions

Invasive Fungal InfectionsHematologic NeoplasmsNeutropeniaImmune Reconstitution Inflammatory SyndromeGenetic Predisposition to Disease

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfectionsNeoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesAgranulocytosisLeukopeniaCytopeniaLeukocyte DisordersImmune System DiseasesDisease SusceptibilityDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

August 2, 2013

First Posted

August 5, 2013

Study Start

November 19, 2013

Primary Completion

June 1, 2017

Study Completion

February 28, 2018

Last Updated

September 8, 2025

Record last verified: 2025-09

Locations

FR(1)