Breast CancerITACTsNCT02866591
Interest of Self-compression Technique on Tolerance of Mammography
A study testing mammography according to an auto-compression procedure, mammography according to a standard procedure and questionary in people with Breast Cancer, run by Institut de Cancérologie de Lorraine at 6 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- mammography according to an auto-compression procedure, mammography according to a standard procedure and questionary
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 6 sitesFrance
- Study dates
- May 2013to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Institut Bergonié
Bordeaux, 33000
Centre François Baclesse
Caen, 14076
Cabinet de radiologie
Nancy, 54000
Polyclinique Majorelle
Nancy, 54000
Institut Curie
Paris, 75248
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54519
About this study
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.
- Conditions
- Breast Cancer
- Being tested
- mammography according to an auto-compression procedure, mammography according to a standard procedure, questionary
- Keywords
- mammography, pain, quality of life, screening, image quality, radiology
- Medical subject headings
- Breast Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mammography according to an auto-compression procedureOther
mammography according to a standard procedureOther
questionaryOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: mammography according to an auto-compression procedure; Other: questionary |
| Arm B | Active comparator | Patients have a mammography performed by the radiologist according to standard procedure. Receives: Other: mammography according to a standard procedure; Other: questionary |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Secondary outcomes (6)
Overall tolerance of mammography
The overall tolerance of mammography will be assessed by the patient after 4 shots. The pain felt by the patient will be assessed using a visual analog scale.
Measured: 1 day
Breast compression force
Value measured on compressive force console (Newtons)
Measured: 1 day
Thickness / compressing force ratio
Measured: 1 day
Image quality
The image quality will be assessed by the radiologist with a quotation of motion blurring on a 4-point scale
Measured: 1 day
Overall assessment of the manipulator
The appreciation of the manipulator will be assessed using a 4-point scale
Measured: 1 day
Overall assessment of self-satisfaction of the patient at the end of the examination
The measurement of patient satisfaction will be evaluated using a self-administered Norwegian questionnaire (MammoGraphy Questionnaire)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study startMay 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 550 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de Lorraine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- HENROT Philippe, MD, Principal investigator, Institut de Cancérologie de Lorraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02866591
- Sponsor's protocol ID
- 2012-A00248-35
- Acronym
- ITACTs
- Status last verified
- Aug 2018
- First submitted
- 10 Aug 2016
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 30715083
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Self-compression Technique on Tolerance of Mammography
- ClinicalTrials.gov ID
- NCT02866591
- Acronym / sponsor ID
- ITACTs / 2012-A00248-35
- Conditions
- Breast Cancer
- Keywords
- mammography, pain, quality of life, screening, image quality, radiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 550 participants (actual)
- Lead sponsor
- Institut de Cancérologie de LorraineUniversity, hospital or other
- Study start
- May 2013 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 15 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Other: mammography according to an auto-compression procedure, Other: questionaryPatients 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. |
| Arm B | Active comparator | Other: mammography according to a standard procedure, Other: questionaryPatients have a mammography performed by the radiologist according to standard procedure. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mammography according to an auto-compression procedure | Other | Arm A |
| mammography according to a standard procedure | Other | Arm B |
| questionary | Other | Arm A, Arm B |
Primary outcome
Comparison of two breast compression techniques (auto-compression versus standard procedure) in mammography
Time frame: 1 day
The comparison will be evaluated by the thickness (mm) of breast compressed
6 secondary outcomes
Overall tolerance of mammography
Time frame: 1 day
Breast compression force
Time frame: 1 day
Thickness / compressing force ratio
Time frame: 1 day
Image quality
Time frame: 1 day
Overall assessment of the manipulator
Time frame: 1 day
Overall assessment of self-satisfaction of the patient at the end of the examination
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
- Derived from this study: PubMed 30715083Henrot 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
HENROT Philippe, MD principal investigator
Institut de Cancérologie de Lorraine
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mammography according to an auto-compression procedure, mammography according to a standard procedure and questionary in people with Breast Cancer, run by Institut de Cancérologie de Lorraine at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of two breast compression techniques (auto-compression versus standard procedure) in mammography (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02866591, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2018.