NCT02866591

Brief Summary

Mammography is used for screening, diagnosis, therapeutic evaluation and monitoring of local cancer breast. It is sometimes poorly tolerated by some patients who complain of an uncomfortable examination or pain. Breast compression by the manipulator aims to reduce the thickness of the breast during mammography; This act is an important factor of pain or discomfort felt by the patient. But, it is also an image quality factor. This study aimed to compare self-breast compression by the patient to the compression standard technique carried out by the manipulator.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
550

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started May 2013

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 15, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

August 8, 2018

Status Verified

August 1, 2018

Enrollment Period

3.6 years

First QC Date

August 10, 2016

Last Update Submit

August 7, 2018

Conditions

Breast Cancer

Keywords

mammographypainquality of lifescreeningimage qualityradiology

Outcome Measures

Primary Outcomes (1)

  • Comparison of two breast compression techniques (auto-compression versus standard procedure) in mammography

    The comparison will be evaluated by the thickness (mm) of breast compressed

    1 day

Secondary Outcomes (6)

  • Overall tolerance of mammography

    1 day

  • Breast compression force

    1 day

  • Thickness / compressing force ratio

    1 day

  • Image quality

    1 day

  • Overall assessment of the manipulator

    1 day

  • +1 more secondary outcomes

Study Arms (2)

Arm A

EXPERIMENTAL

Patients have a mammography performed by themselves according to auto-compression procedure. The radiologist leads the compression at a minimum threshold of 40 Newton, then leaves the control of the compression to the patient. The radiologist treats only the positioning of the breast on the sensor.

Other: mammography according to an auto-compression procedureOther: questionary

Arm B

ACTIVE COMPARATOR

Patients have a mammography performed by the radiologist according to standard procedure.

Other: mammography according to a standard procedureOther: questionary

Interventions

mammography according to an auto-compression procedureOTHER
Arm A
mammography according to a standard procedureOTHER
Arm B
questionaryOTHER
Arm AArm B

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients ≥ 18 years and ≤ 75 years of age
  • ECOG performance \<2
  • Mammography planned as part of a breast cancer screening or a monitoring following treatment of a breast lesion
  • Ability to provide written informed consent
  • Patient's legal capacity to consent to study participation and to understand and comply with the requirements of the study.

You may not qualify if:

  • Eastern Cooperative Oncology Group performance status ≥ 2
  • Treatment for benign lesion with surgery for less than 3 years
  • Treatment for cancer with surgery and / or radiotherapy for less than 3 years
  • Biopsy for less than 1 year
  • Breast prosthesis
  • Mastectomy
  • Assessment motivated by a clinical breast abnormality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Institut Bergonié

Bordeaux, 33000, France

Location

Centre François Baclesse

Caen, 14076, France

Location

Cabinet de radiologie

Nancy, 54000, France

Location

Polyclinique Majorelle

Nancy, 54000, France

Location

Institut Curie

Paris, 75248, France

Location

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

Location

Related Publications (1)

  • Henrot P, Boisserie-Lacroix M, Boute V, Troufleau P, Boyer B, Lesanne G, Gillon V, Desandes E, Netter E, Saadate M, Tardivon A, Grentzinger C, Salleron J, Oldrini G. Self-compression Technique vs Standard Compression in Mammography: A Randomized Clinical Trial. JAMA Intern Med. 2019 Mar 1;179(3):407-414. doi: 10.1001/jamainternmed.2018.7169.

    PMID: 30715083DERIVED

MeSH Terms

Conditions

Breast NeoplasmsPain

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • HENROT Philippe, MD

    Institut de Cancérologie de Lorraine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2016

First Posted

August 15, 2016

Study Start

May 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

August 8, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(6)