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

NCT03506529 | Completed

• 1 other identifier: 2017-A03545-48
• Study Type: observational
• Target: 644
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Anal Cancer

Keywords

TEP; hypermetabolism

Outcome Measures

Primary Outcomes (4)

• 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

• PET analysis of hypermetabolism of the anal canal

  Visual analysis of hypermetabolism of the anal canal on a 3-point scale: 0: no hypermetabolism 1. moderate hypermetabolism 2. intense hypermetabolism

  Only at the day of inclusion, during an appointment for a TEP exam

• 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

• 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

Interventions

questionnary OTHER

questionnary on predictif factors about physiological hypermetabolism of anal canal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any patient coming for a PET

You may qualify if:

• Patient 18 years old
• Patient referred for 18F-FDG PET

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Francois Baclesse: lead

Study Sites (2)

CHU

Caen, 14000, France

Location

Centre François Baclesse

Caen, 14076, France

Location

Related Publications (1)

• Aide N, Tainturier LE, Nganoa C, Houdu B, Kammerer J, Galais MP, Ciappuccini R, Lasnon C. HYPHYCA: a prospective study in 613 patients conducting a comprehensive analysis for predictive factors of physiological 18F-FDG anal uptake. EJNMMI Res. 2020 Mar 20;10(1):28. doi: 10.1186/s13550-020-0615-5.

  PMID: 32193623 DERIVED

MeSH Terms

Conditions

Anus Neoplasms

Condition Hierarchy (Ancestors)

Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2018
• First Posted: April 24, 2018
• Study Start: September 17, 2018
• Primary Completion: November 15, 2018
• Study Completion: November 15, 2018
• Last Updated: January 11, 2019

Record last verified: 2019-01

Locations

FR (2)