Informations générales (source: ClinicalTrials.gov)
Intérêt Des Images Tardives Pour le Bilan d'Extensions en TEP-TDM au 18FGD Des Cancers de Vessie Infiltrant le Muscle (TARDITEP) (TARDITEP)
Interventional
N/A
Hopital Foch (Voir sur ClinicalTrials)
décembre 2023
mars 2027
06 août 2024
The goal of this study is to demonstrate a significant gain in sensitivity versus
surgical curage (extended pelvic) for initial lymph node staging of late FDG-PET images
(2.5 hours) versus standard images (1 hour), analyzed by side (right iliac/left iliac
areas in Patients with muscle-invasive bladder tumor (MIBT) (≥pT2) referred for FDG-PET
in the nuclear medicine department of Hôpital Foch as part of their initial extension
workup.
Before performing 18FDG PET-CT, the operator checks that the patient has fasted for at
least 6 hours and that blood glucose levels are below 11 mmol/l. In the absence of
contraindication, intravenous (IV) injection of the radiopharmaceutical (18FDG at a dose
of 3 MBq/kg) and a diuretic (Furosemide 20mg) will be performed as part of routine care.
The 18FDG PET-CT scan will be performed in 2 phases:
1st phase: Standard acquisition (vertex to mid-thigh) at 1 hour post-injection of
radiotracer. PET acquisition is coupled to a "base-dose" CT scan in spontaneous contrast,
for anatomical location, measurement of lymph node size, and creation of an attenuation
map, necessary for correction of attenuation and diffusion on PET images (DLP estimated
at around 500 mGy.cm on average). Micturition is performed as part of routine care just
before the first acquisition.
Phase 2: Complementary abdomino-pelvic acquisition at 2.5 hours post-injection (2 or 3
steps depending on patient size. This second PET acquisition is coupled to an
"ultra-base-dose" CT scan in spontaneous contrast, to be used only for attenuation and
diffusion correction (DLP estimated at around 100 mGy.cm on average). Micturition is
performed 30 minutes before the second acquisition.
The patient's proposed therapeutic management will be decided at the PCR once the
extension work-up has been carried out, as part of routine care. For this purpose, only
"standard" 18FDG PET-CT images may be used.
As a general rule, patients with distant metastases (stage pT2N+M+) will receive
palliative treatment, while surgical treatment from the outset, or after chemotherapy for
patients with stage pT2N0M0 or pT2N+M0, will be discussed on a case-by-case basis at the
multidisciplinary consultation meeting.
Late" images will be used after lymph node curage, in patients who have not had
chemotherapy prior to surgery (cystectomy + extended pelvic lymph node curage), to
determine the sensitivity of these complementary images.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FOCH | Léa TURPIN | 05/05/2025 07:12:15 | Contacter | ||
Critères
Tous
Inclusion Criteria:
- Patient 18 years of age or older,
- With histologically proven muscle-invasive bladder cancer (≥pT2) at endoscopic
bladder resection,
- Scheduled to undergo 18FDG PET-CT in the nuclear medicine department at Hôpital
Foch,
- Having signed a consent form,
- Affiliated to a health insurance scheme.
- Patient 18 years of age or older,
- With histologically proven muscle-invasive bladder cancer (≥pT2) at endoscopic
bladder resection,
- Scheduled to undergo 18FDG PET-CT in the nuclear medicine department at Hôpital
Foch,
- Having signed a consent form,
- Affiliated to a health insurance scheme.
- Patient with a history of pelvic or genitourinary cancer,
- Patient with known metastatic disease,
- Patient with a contraindication to 18FDG PET-CT,
- Pregnant or breast-feeding woman,
- Patient deprived of liberty or under guardianship.