Identification of Predictive Factors for Physiological Hypermetabolism of the Anal Canal in 18F-FDG PET / CT

Anal Cancer Clinical Trial

— HYPHYCA  

Official title:

Identification of Predictive Factors for Physiological Hypermetabolism of the Anal Canal in 18F-FDG PET / CT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03506529
• Other study ID #: 2017-A03545-48
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Anal Cancer
• Anus Neoplasms

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