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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03506529
Other study ID # 2017-A03545-48
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 17, 2018
Est. completion date November 15, 2018

Study information

Verified date January 2019
Source Centre Francois Baclesse
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Questionnaire to be completed by patients coming for PET to identify the predictive factors of physiological hypermetabolism of the anal canal


Recruitment information / eligibility

Status Completed
Enrollment 644
Est. completion date November 15, 2018
Est. primary completion date November 15, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patient 18 years old

- Patient referred for 18F-FDG PET

Exclusion Criteria:

- History of surgery or anal and / or perineal and / or pelvic radiotherapy, whatever the indication

- Patient deprived of liberty, under tutorship or curatorship

- Any associated socio-educational, medical or psychological condition that could compromise the patient's ability to participate in the study (eg illiteracy, mental retardation, etc.)

- Pregnant woman (classic contraindication of a PET scan)

- Opposition of the patient to participate in the study

Study Design


Related Conditions & MeSH terms


Intervention

Other:
questionnary
questionnary on predictif factors about physiological hypermetabolism of anal canal

Locations

Country Name City State
France Centre François Baclesse Caen
France CHU Caen

Sponsors (1)

Lead Sponsor Collaborator
Centre Francois Baclesse

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Description of predictive factors for physiological hypermetabolism of the anal canal in 18F-FDG PET / CT Confrontation in participants of hypermetabolism of the anal canal in PET with:
number of stool/day and consistency of stool, medical history (by Answers to the specific questionnaire designed for the study)
Only at the day of inclusion, during an appointment for a TEP exam
Primary PET analysis of hypermetabolism of the anal canal Visual analysis of hypermetabolism of the anal canal on a 3-point scale:
0: no hypermetabolism
moderate hypermetabolism
intense hypermetabolism
Only at the day of inclusion, during an appointment for a TEP exam
Primary CT scan with measurement measurement of the largest rectal diameter in mm. Only at the day of inclusion, during an appointment for a TEP exam
Primary CT scan with measurement Visual assessment of the rectal capacity on a 3-point scale (0, 1, 2) and content characteristics (air, feces, air and feces). Only at the day of inclusion, during an appointment for a TEP exam
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