Breast CancerNCT05458739
The ClearCoast™ Magnetic Resonance Outcome PMS Study
An observational study of Breast Cancer, run by Clear Cut Medical Ltd. at 2 sites in 2 countries.
Trial summary
Post Marketing Surveillance (PMS) study. Up to 93 patients undergoing breast conserving surgery will be enrolled in a prospective, single center, non-randomized controlled study, and a corresponding number of historical patients that underwent BCS will serve as the historical control group, accounting for a 1:1 ratio. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- ClearCoast MR System
- Type of treatment
- Medical device
- How many people
- 93 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 24 Jun 2021to 1 Aug 2024
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Study population will consist of women 18 years of age and/or over, who are diagnosed with invasive and/or in situ carcinoma of the breast.
Who may be able to join
- Women histologically diagnosed with invasive and/or in situ carcinoma of the breast, undergoing primary lumpectomy (partial mastectomy) procedure
- Age ≥18
- Patient is willing and capable to provide written Informed Consent Form (ICF)
Who cannot join
- Prior surgical procedure in the same breast within 12 months prior to the surgery date
- Recurrent breast cancer surgery
- Neoadjuvant chemotherapy and/or neoadjuvant hormone therapy
- Previous radiation therapy in the operated breast
- Pregnancy
- Lactation
Show all 13Show fewer
- Patient has subglandular breast implants in the operated breast
- moribund patient and/or patient with comorbidities, per principal investigator discretion
- Participating in any other investigational study for either drug or device which might influence collection of valid data under this study.
- Intraoperative:
- Specimen undergoing pathological specimen assessment (e.g. by frozen section, imprint cytology or gross assessment by sectioning), resulting in deformation of specimen shape/tissue properties (e.g. Formalin conservation)
- Specimen dimension is larger than the Tissue container volume (200cc)
- Inability to define aspect color/orientation and/or margin border
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United Kingdom1 site
Western General Hospital , Breast Unit
Edinburgh, Scotland
About this study
Official title: The ClearCoast™ Magnetic Resonance Outcome Post Marketing Surveillance Study
Post Marketing Surveillance (PMS) study. Up to 93 patients undergoing breast conserving surgery will be enrolled in a prospective, single center, non-randomized controlled study, and a corresponding number of historical patients that underwent BCS will serve as the historical control group, accounting for a 1:1 ratio. All study patients and the patients in the historical control group will be required to meet the study eligibility criteria.
BCS will be performed with the routine standard of care (SOC), including intra-operative methods used to improve margin assessment. In addition to SOC process, the main specimen from patients found eligible will be scanned in the ClearCoast™ system. The surgeon will utilize the information from the ClearCoast images in his margin assessments evaluation which includes the diffusion at the surface of a particular aspect (suggesting irregular tissue at the specimen's surface), and decide whether to excise additional tissue. The decision-making process including MR images interpretation and the surgical decisions will be evaluated and documented. Following procedure, routine histopathology examination will be performed accompanied by the ClearCoast optical and parametric maps.
Read more
This study is a controlled design, in which subjects previously having undergone BCS by the same surgeons, will serve as the historical control group, comparing the following endpoints:
- Complete surgical re-excision rate
- Total excised breast tissue volume
The study Control group is composed of historical data from patients previously undergone BCS, under the same site SOC surgical practice, practicing surgeons, and study eligible criteria. This allows reducing inter-group variability and bias.
A device operator trained by ClearCut Medical will operate the device throughout the study.
- Conditions
- Breast Cancer
- Being tested
- ClearCoast MR System
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClearCoast MR SystemDevice
The removed specimen is scanned using the ClearCoast MR System.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | The removed specimen (as part of BCS) is scanned with the ClearCoast MR System. Receives: Device: ClearCoast MR System | |
| Historical Group | Historical data of patients undergone BCS, under the same eligibility criteria and performed by the same study surgeons, thus minimizing inter-groups and inter-surgeon variability and bias, will serve as a control group for the comparison of the complete resection rate. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ClearCoast™ Success rate
the success of the ClearCoast™ system indicating abnormal margins of breast tissue specimen intra-operatively.
This endpoint compares the proportion of patients that undergo a re-excision surgery following the primary lumpectomy procedure between the two groups.
Measured: 6 months
Secondary outcomes (1)
Secondary Outcome - Re-excision rate
Comparing the percentage of positive margins (%) of the main specimen (as detected by post-operative microscopically as having cancer within 1mm or less of the inked surface) and document which of those positive margins have been addressed by intra-operative re-excision or the absence of further tissue to be re-excised (e.g., undermining the skin or reaching the pectoralis fascia).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start24 Jun 2021
- Primary completion1 Jul 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clear Cut Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05458739
- Sponsor's protocol ID
- 735CLD Rev.04
- Status last verified
- Aug 2024
- First submitted
- 7 Jul 2022
- Last updated
- 21 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ClearCoast™ Magnetic Resonance Outcome Post Marketing Surveillance Study
- ClinicalTrials.gov ID
- NCT05458739
- Acronym / sponsor ID
- 735CLD Rev.04
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Clear Cut Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Jun 2021 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 14 Jul 2022 (actual)
- 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.
Post Marketing Surveillance (PMS) study. Up to 93 patients undergoing breast conserving surgery will be enrolled in a prospective, single center, non-randomized controlled study, and a corresponding number of historical patients that underwent BCS will serve as the historical control group, accounting for a 1:1 ratio. All study patients and the patients in the historical control group will be required to meet the study eligibility criteria.
BCS will be performed with the routine standard of care (SOC), including intra-operative methods used to improve margin assessment. In addition to SOC process, the main specimen from patients found eligible will be scanned in the ClearCoast™ system. The surgeon will utilize the information from the ClearCoast images in his margin assessments evaluation which includes the diffusion at the surface of a particular aspect (suggesting irregular tissue at the specimen's surface), and decide whether to excise additional tissue. The decision-making process including MR images interpretation and the surgical decisions will be evaluated and documented. Following procedure, routine histopathology examination will be performed accompanied by the ClearCoast optical and parametric maps.
This study is a controlled design, in which subjects previously having undergone BCS by the same surgeons, will serve as the historical control group, comparing the following endpoints:
- Complete surgical re-excision rate
- Total excised breast tissue volume
The study Control group is composed of historical data from patients previously undergone BCS, under the same site SOC surgical practice, practicing surgeons, and study eligible criteria. This allows reducing inter-group variability and bias.
A device operator trained by ClearCut Medical will operate the device throughout the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | – | Device: ClearCoast MR SystemThe removed specimen (as part of BCS) is scanned with the ClearCoast MR System. |
| Historical Group | – | –Historical data of patients undergone BCS, under the same eligibility criteria and performed by the same study surgeons, thus minimizing inter-groups and inter-surgeon variability and bias, will serve as a control group for the comparison of the complete resection rate. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population will consist of women 18 years of age and/or over, who are diagnosed with invasive and/or in situ carcinoma of the breast.
Key inclusion criteria (3 listed)
- Women histologically diagnosed with invasive and/or in situ carcinoma of the breast, undergoing primary lumpectomy (partial mastectomy) procedure
- Age ≥18
- Patient is willing and capable to provide written Informed Consent Form (ICF)
Key exclusion criteria (13 listed)
- Prior surgical procedure in the same breast within 12 months prior to the surgery date
- Recurrent breast cancer surgery
- Neoadjuvant chemotherapy and/or neoadjuvant hormone therapy
- Previous radiation therapy in the operated breast
- Pregnancy
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 |
|---|---|---|
| ClearCoast MR SystemThe removed specimen is scanned using the ClearCoast MR System. | Device | Treatment Group |
Primary outcome
ClearCoast™ Success rate
Time frame: 6 months
the success of the ClearCoast™ system indicating abnormal margins of breast tissue specimen intra-operatively. This endpoint compares the proportion of patients that undergo a re-excision surgery following the primary lumpectomy procedure between the two groups.
1 secondary outcome
Secondary Outcome - Re-excision rate
Time frame: 1 year
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 21 Aug 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Clear Cut Medical Ltd. at 2 sites in 2 countries.
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 3 inclusion and 13 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 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, United Kingdom. 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?
ClearCoast™ Success rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2024.