Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06537960
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
Interest of Late Images for the Assessment of Extensions in 18FGD PET-CT of Muscle-Invasive Bladder Cancers
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Intérêt Des Images Tardives Pour le Bilan dExtensions en TEP-TDM au 18FGD Des Cancers de Vessie Infiltrant le Muscle TARDITEP
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TARDITEP
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 25 hours versus standard images 1 hour analyzed by side right iliacleft 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 mmoll In the absence of contraindication intravenous IV injection of the radiopharmaceutical 18FDG at a dose of 3 MBqkg 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 mGycm on average Micturition is performed as part of routine care just before the first acquisition
Phase 2 Complementary abdomino-pelvic acquisition at 25 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 mGycm on average Micturition is performed 30 minutes before the second acquisition
The patients 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 pT2NM will receive palliative treatment while surgical treatment from the outset or after chemotherapy for patients with stage pT2N0M0 or pT2NM0 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
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 mmoll In the absence of contraindication intravenous IV injection of the radiopharmaceutical 18FDG at a dose of 3 MBqkg 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 mGycm on average Micturition is performed as part of routine care just before the first acquisition
Phase 2 Complementary abdomino-pelvic acquisition at 25 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 mGycm on average Micturition is performed 30 minutes before the second acquisition
The patients 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 pT2NM will receive palliative treatment while surgical treatment from the outset or after chemotherapy for patients with stage pT2N0M0 or pT2NM0 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None