Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:15 AM
Ignite Modification Date:
2025-12-25 @ 1:15 AM
NCT ID:
NCT04938193
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.
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.
Study:
NCT04938193
Study Brief:
Protocol Section:
NCT04938193