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Muscle-Invasive Bladder CarcinomaTARDITEPNCT06537960

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

A study testing 18FDG PET-CT in people with Muscle-Invasive Bladder Carcinoma and Bladder Cancer, run by Hopital Foch at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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)… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
18FDG PET-CT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteFrance
Study dates
14 Dec 2023to 15 Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

France1 site, 1 recruiting
  • Hopital Foch

    Suresnes, Île-de-France Region, 92150

    MARC BERTAUX, MD, 00 33 1 46 25 11 94, drci.promotion@hopital-foch.com

    Recruiting

Other trials in France

About this study

Official title: Intérêt Des Images Tardives Pour le Bilan d'Extensions en TEP-TDM au 18FGD Des Cancers de Vessie Infiltrant le Muscle (TARDITEP)

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:

Read more

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.

Being tested
18FDG PET-CT
Medical subject headings
Urinary Bladder Neoplasms

What participants receive

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

  • 18FDG PET-CTProcedure or surgery

    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.
Study groups in NCT06537960
Study groupRoleWhat they receive
18FDG PET-CTOther18FDG 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.
Receives: Procedure: 18FDG PET-CT

What is being measured

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

  1. Sensitivity versus lymph node curage (per side)

    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).

    Measured: 39 months

Timeline

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

  1. First posted5 Aug 2024
  2. Study start14 Dec 2023
  3. Primary completion15 Mar 2027 (estimated)
  4. Study completion15 Mar 2027 (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 N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06537960
Sponsor's protocol ID
2021_0151
Acronym
TARDITEP
Status last verified
Nov 2025
First submitted
30 Jul 2024
Last updated
21 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing 18FDG PET-CT in people with Muscle-Invasive Bladder Carcinoma and Bladder Cancer, run by Hopital Foch 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 21 Nov 2025. 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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact MARC BERTAUX, Dr (00 33 1 46 25 11 94, drci.promotion@hopital-foch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitivity versus lymph node curage (per side) (time frame: 39 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 21 Nov 2025.

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