Interest of Late Images for the Assessment of Extensions in 18FGD PET-CT of Muscle-Invasive Bladder Cancers

Not Applicable

Recruiting

• Conditions: Bladder Cancer; Muscle-Invasive Bladder Carcinoma
• Interventions: Procedure: 18FDG PET-CT

• Registration Number: NCT06537960
• Lead Sponsor: Hopital Foch

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-14
• Study First Submitted: 2024-07-30
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-02
• Last Update Submitted: 2024-08-02
• Study First Posted: 2024-08-05
• Last Update Posted: 2024-08-05
• Primary Completion: 2027-03-15
• Study Completion: 2027-03-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 66

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.

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
18FDG PET-CT	18FDG PET-CT	18FDG PET-CT will be performed in 2 phases: 1. st standard phase: Standard acquisition (vertex to mid-thigh) at 1 hour post-injection of radiotracer 2. nd phase: Complementary abdomino-pelvic acquisition at 2.5 hours post radiotracer injection.

Primary Outcome Measures

Name	Time	Method
Sensitivity versus lymph node curage (per side)	39 months	Sensitivity versus lymph node curage (per side) for a blinded visual analysis, by two experts, with joint rereading in the event of discordance, of the two sets of images (1h and 2h30 post-injection), in patients who have not had chemotherapy prior to surgery (cystectomy + extensive pelvic lymph node curage).

Trial Locations

Locations (1)

Hopital Foch; 🇫🇷 Suresnes, Ile De France, France