AzTrials
AzTrials

Prosthetic Joint InfectionPhase 2Gal-I-TEPNCT04938193

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

A Phase 2 study testing 68Ga-citrate PET/CT in people with Prosthetic Joint Infection, run by University Hospital, Bordeaux at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Prosthetic Joint Infection
What is being tested?
68Ga-citrate PET/CT
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteFrance
Study dates
2 Feb 2022to Feb 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • Having signed an informed consent form (later than the day of inclusion and before any examination required by the research)

Who cannot join

  • 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).
  • Subject in relative exclusion period from another study protocol.
  • Known contraindications to PET exam with radiopharmaceutical injection (hypersensitivity to radiopharmaceutical and/or to excipients).

Trial locations and contacts

1 site in 1 country.

Frédéric-Antoine DAUCHY, MD contact

05 56 79 55 36 ext. +33

frederic.dauchy@chu-bordeaux.fr

Pauline PERREAU contact

pauline.perreau@chu-bordeaux.fr

France1 site, 1 recruiting

  • CHU de Bordeaux - service de maladies infectieuses

    Bordeaux

    Frédéric-Antoine DAUCHY, MD, frederic.dauchy@chu-bordeaux.fr

    Pauline PERREAU, pauline.perreau@chu-bordeaux.fr

    Recruiting

Other trials in France

About this study

Official title: 68Gallium-citrate Positron Emission Tomography/Computed Tomography (68Ga-citrate PET/CT) for the Diagnosis of Chronic Prosthetic Hip or Knee Infection

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.

Read the detailed description

Prosthetic joint infection (PJI) is a serious and rare complication of orthopedic surgery. Diagnosis is based on precise criteria (MSIS criteria Musculoskeletal Infection Society). However, diagnosis can be difficult, in particular when the infection is present for more than one month. One of the usual exams is bone scintigraphy and 99mTc-HMPAO-labelled leukocyte scintigraphy. This imaging allows an accurate assessment but it has some limitations since it requires ex vivo isolation and marking of patient's leukocytes and repeated acquisition for 24 hours. 68Gallium-citrate positron emission tomography/computed tomography (68Ga-citrate PET/CT) has been recently developed. 68Ga-citrate PET/CT is innovative compared to [18F]fluorodeoxyglucose PET/CT (18F-FDG PET/CT) and has many advantages: high resolution, realization in only two hours, short radioactive period and no handling of patient's leukocytes. Furthermore, preliminary data indicate that 68Ga-citrate is picked up by immune cells, which makes this exam inflammation-selective. To date, 68Ga-citrate PET/CT has not been specifically assessed in PJI, it is the objective of the present study:

Prospective study using 68Ga- citrate PET/CT and a 99mTc-HMPAO-labelled leukocyte SPECT/CT. Patients referred for a suspected PJI and with a positive bone scintigraphy will be prospectively enrolled. After information and signature of informed consent, patients will benefit from a 68Ga citrate PET/CT, in addition to leukocyte scintigraphy in a two-week period. Both images will be anonymized and interpreted by two independent nuclear physicians.

Final PJI diagnosis is based on reference criteria (MSIS) to ensure diagnosis during the standardized medical follow-up. Patients will be followed until 12 months after the leukocyte scintigraphy.

Being tested
68Ga-citrate PET/CT

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 68Ga-citrate PET/CTDiagnostic test

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

Study groups in NCT04938193
Study groupRoleWhat they receive
68Ga-citrate PET/CTExperimentalNot described
Receives: Diagnostic Test: 68Ga-citrate PET/CT

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 12 months after baseline (Day 0)

Secondary outcomes (5)

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

    Area under ROC curve (AUROC) for SUVmax ROI and SUVmax ROI/SVmax liver region ratio measured at inclusion.

    Reference test : Musculoskeletal Infection Society (MSIS) criteria assessed up to 12 months after inclusion.

    Measured: Up to 12 months after baseline (Day 0)

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

    Intraclass correlation coefficient and/or Cohen's Kappa.

    Measured: Up to 12 months after baseline (Day 0)

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

    Sensibility, specificity, positive and negative predictive values. Index test : leukocytes scintigraphy at inclusion. Reference test : Musculoskeletal Infection Society (MSIS) criteria assessed up to 12 months after inclusion.

    Measured: Up to 12 months after baseline (Day 0)

  4. 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.

    Sensibility, specificity, positive and negative predictive values, in each subgroup.

    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.

    Measured: Up to 12 months after baseline (Day 0)

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

    Sensibility, specificity, positive and negative predictive values. Reference test : Musculoskeletal Infection Society (MSIS) criteria assessed up to 12 months after inclusion.

    Index test : 68Ga citrate PET / CT scan CT at inclusion and leukocytes scintigraphy at inclusion.

    Measured: Up to 12 months after baseline (Day 0)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2021
  2. Study start2 Feb 2022
  3. Primary completionFeb 2025 (estimated)
  4. Study completionFeb 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04938193
Sponsor's protocol ID
CHUBX 2019/24
Acronym
Gal-I-TEP
Status last verified
Jan 2023
First submitted
16 Jun 2021
Last updated
23 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 68Ga-citrate PET/CT in people with Prosthetic Joint Infection, run by University Hospital, Bordeaux at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Frédéric-Antoine DAUCHY, MD (05 56 79 55 36 ext. +33, frederic.dauchy@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnostic accuracy of 68Ga citrate PET / CT scan CT for chronic prosthetic hip or knee infection (time frame: Up to 12 months after baseline (Day 0)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04938193.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in