68Ga-citrate PET/CT for the Diagnosis of Chronic Prosthetic Hip or Knee Infection

NCT04938193 | Unknown Phase 2

• 1 other identifier: CHUBX 2019/24
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Diagnosis of chronic prosthetic joint infection (PJI) can be difficult. 68Ga-citrate Positron Emission Tomography/Computed Tomography (PET/CT) has been recently developed and has many advantages such as high resolution and low radiation exposure. To date, 68Ga-citrate PET/CT has not been specifically assessed in prosthetic joint infection. In this prospective study, patients referred for a suspected PJI will benefit from both a 68Ga-citrate PET/CT and a 99mTc-HMPAO-labelled leukocyte SPECT/CT. The primary outcome is the assessment of the 68Ga-citrate PET/CT accuracy for the diagnosis of chronic prosthetic hip or knee infection.

Conditions

Prosthetic Joint Infection

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of 68Ga citrate PET / CT scan CT for chronic prosthetic hip or knee infection

  Sensibility, specificity, positive and negative predictive value. Index test : 68Ga citrate PET / CT scan CT at inclusion. Reference test : Musculoskeletal Infection Society (MSIS) criteria assessed up to 12 months after inclusion. After 12 months, participants will be considered free of chronic prosthetic hip or knee infection.

  Up to 12 months after baseline (Day 0)

Secondary Outcomes (5)

• Diagnostic accuracy of quantitative 68Ga citrate PET / CT scan for chronic prosthetic hip or knee infection

  Up to 12 months after baseline (Day 0)

• Inter-observer reproducibility of 68Ga-citrate PET/CT interpretation

  Up to 12 months after baseline (Day 0)

• Diagnostic accuracy of leukocyte scintigraphy for chronic prosthetic hip or knee infection

  Up to 12 months after baseline (Day 0)

• Diagnosis accuracy of 68Ga-citrate PET/CT and leukocytes scintigraphy for chronic prosthetic hip or knee infection in the following sub-groups: prosthetic knee or hip infection.

  Up to 12 months after baseline (Day 0)

• Comparison of diagnostic accuracy of 68Ga-PET/CT and leukocytes scintigraphy for chronic prosthetic hip or knee infection

  Up to 12 months after baseline (Day 0)

Study Arms (1)

68Ga-citrate PET/CT

EXPERIMENTAL

Diagnostic Test: 68Ga-citrate PET/CT

Interventions

68Ga-citrate PET/CT DIAGNOSTIC_TEST

PET/CT Imaging with 68Ga-citrate PET/CT injection

68Ga-citrate PET/CT

Eligibility Criteria

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

You may qualify if:

• Patient aged over 18 years old
• Patient referred for the first time to the South-Western France referral center for complex bone and joint infections (Crioac GSO, infectious diseases and orthopedic surgery units) for suspicion of prosthetic hip or knee infection.
• Suspicion of prosthetic joint infection evolving for more than one month.
• Patient for who routine diagnosis includes both bone scintigraphy and leukocytes scintigraphy.
• Patient with positive bone scintigraphy.
• Being affiliated to a health insurance system

You may not qualify if:

• Patient with active cancer.
• Patient with negative bone scintigraphy.
• Patient who cannot stop antibiotics 14 days before exams.
• Pregnant or breastfeeding women.
• Women of childbearing age but not using effective means of contraception.
• Patient concerned by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent).
• Known contraindications to PET exam with radiopharmaceutical injection (hypersensitivity to radiopharmaceutical and/or to excipients).

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU de Bordeaux - service de maladies infectieuses

Bordeaux, France

RECRUITING

Study Officials

• Frédéric-Antoine DAUCHY, MD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

• Eric FRISON, MD

  University Hospital, Bordeaux

  STUDY CHAIR

Central Study Contacts

Frédéric-Antoine DAUCHY, MD

CONTACT

05 56 79 55 36; frederic.dauchy@chu-bordeaux.fr

Pauline PERREAU

CONTACT

pauline.perreau@chu-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: June 24, 2021
• Study Start: February 2, 2022
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: January 23, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)