Breast CancerNCT05395936

Mastectomy Flap Temperature Study

A study testing Myocardial Probe Temperature Screen and Data Collection in people with Breast Cancer and Mastectomy, run by Wake Forest University Health Sciences at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this research study is to measure tissue temperatures and generate a prospective database of participants undergoing mastectomy with or without breast reconstruction at Wake Forest Baptist Hospital (WFBH) in order to enable and facilitate the evaluation of important and novel research questions - and… Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Cancer, Mastectomy
What is being tested?: Myocardial Probe Temperature Screen and Data Collection
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 1 siteUnited States
Study dates: 29 Sep 2022to 17 Mar 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

Scheduled for unilateral or bilateral mastectomy with implant based breast reconstruction within the Wake Forest Baptist Health System.
Aged 18 or older.
Ability to understand an IRB-approved informed consent document (either directly or via a legally authorized representative).

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: Mastectomy Flap Temperature and Clinical Implications

Read the detailed description

Primary Objective(s)

Quantify the proportion of eligible women approached who consent to intraoperative (pre and post mastectomy) measurement of mastectomy flap temperatures in each of 4 quadrants of each relevant breast (i.e., unilateral or bilateral procedure).
Quantify the proportion of patients upon whom the surgical team is able to obtain intraoperative flap measurements from each of 4 quadrants on each relevant breast pre- and post-mastectomy and pre-implant.

Secondary Objective: To measure mastectomy flap temperatures in 4 quadrants pre-mastectomy, following mastectomy, and pre-implant, and compare average flap temperature to average core body temperature.

Conditions: Breast Cancer, Mastectomy
Being tested: Myocardial Probe Temperature Screen, Data Collection
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Myocardial Probe Temperature ScreenOther
The myocardial probe is a needle that measures temperatures. The skin site for introducing the myocardial probe will be small enough that participants will not notice that temperatures have been collected. If participants have multiple operations, temperatures may be collected at each operation.
Data CollectionOther
Study team members will collect medical history and other information to potentially understand the safety and success of breast surgery better to allow investigators to identify variables, or changes to help understand investigators roles in potential complications in breast surgery.

Study groups in NCT05395936
Study group	Role	What they receive
Intraoperative Data Collection Arm	Experimental	Participants scheduled for mastectomy with or without breast reconstruction during the course of their breast surgery treatment will have breast skin temperatures taken using a myocardial probe in different anatomical breast areas at multiple time points during the surgery. Receives: Other: Myocardial Probe Temperature Screen; Other: Data Collection

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Women Consenting to Have Mastectomy Flap Temperatures Measured During Surgery
This will be computed by the dividing the total number of eligible women screened by the number of women who consent.
Measured: 90 days post surgery
Number of Women Having All Relevant Flap Temperatures Measured
This will either be 12 or 24 total expected flap temperatures: 4 quadrants, at three time points- pre and post-mastectomy and pre-implant placement; one or both breasts), and we will compute a 95% confidence interval.
Measured: 90 days post surgery

Secondary outcomes (1)

Change in Mastectomy Flap Temperatures and Core Body Temperatures
Mastectomy flap temperatures will be measured using a 22 gauge myocardial temperature sensor (Smiths Medical). Temperatures will be recorded in degrees Celsius. Core body temperature will also be collected to observe a difference between pre and post-mastectomy average mean flap temperature, average core body temperature and pre-implant average core body temperature and flap temperature readings.
Measured: At pre-mastectomy (baseline), pre-implant (before surgery) and post mastectomy (up to 90 days post surgery)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Sep 202217 Mar 2024

First posted27 May 2022
Study start29 Sep 2022
Primary completion17 Mar 2024
Study completion17 Mar 2024

Why it stopped: low accruals

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05395936
Sponsor's protocol ID: IRB00075787
Other IDs: WFBCCC 74222, P30CA012197
Status last verified: Nov 2024
First submitted: 24 May 2022
Last updated: 4 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mastectomy Flap Temperature and Clinical Implications
ClinicalTrials.gov ID: NCT05395936
Acronym / sponsor ID: IRB00075787
Conditions: Breast Cancer, Mastectomy
Study type: Interventional
Recruitment status: TerminatedReason stopped: low accruals
Enrolment: 19 participants (actual)
Lead sponsor: Wake Forest University Health SciencesUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 29 Sep 2022 (actual)
Primary completion: 17 Mar 2024 (actual)
Study completion: 17 Mar 2024 (actual)
First posted: 27 May 2022 (actual)
Results: Posted 4 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Primary Objective(s)

Quantify the proportion of eligible women approached who consent to intraoperative (pre and post mastectomy) measurement of mastectomy flap temperatures in each of 4 quadrants of each relevant breast (i.e., unilateral or bilateral procedure).
Quantify the proportion of patients upon whom the surgical team is able to obtain intraoperative flap measurements from each of 4 quadrants on each relevant breast pre- and post-mastectomy and pre-implant.

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Intraoperative Data Collection Arm	Experimental	Other: Myocardial Probe Temperature Screen, Other: Data CollectionParticipants scheduled for mastectomy with or without breast reconstruction during the course of their breast surgery treatment will have breast skin temperatures taken using a myocardial probe in different anatomical breast areas at multiple time points during the surgery.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Scheduled for unilateral or bilateral mastectomy with implant based breast reconstruction within the Wake Forest Baptist Health System.
Aged 18 or older.
Ability to understand an IRB-approved informed consent document (either directly or via a legally authorized representative).

Key exclusion criteria (0 listed)

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
Myocardial Probe Temperature ScreenThe myocardial probe is a needle that measures temperatures. The skin site for introducing the myocardial probe will be small enough that participants will not notice that temperatures have been collected. If participants have multiple operations, temperatures may be collected at each operation.	Other	Intraoperative Data Collection Arm
Data CollectionStudy team members will collect medical history and other information to potentially understand the safety and success of breast surgery better to allow investigators to identify variables, or changes to help understand investigators roles in potential complications in breast surgery.	Other	Intraoperative Data Collection Arm

Primary outcome

Number of Women Consenting to Have Mastectomy Flap Temperatures Measured During Surgery
Time frame: 90 days post surgery
This will be computed by the dividing the total number of eligible women screened by the number of women who consent.
Number of Women Having All Relevant Flap Temperatures Measured
Time frame: 90 days post surgery
This will either be 12 or 24 total expected flap temperatures: 4 quadrants, at three time points- pre and post-mastectomy and pre-implant placement; one or both breasts), and we will compute a 95% confidence interval.

1 secondary outcome

Change in Mastectomy Flap Temperatures and Core Body Temperatures
Time frame: At pre-mastectomy (baseline), pre-implant (before surgery) and post mastectomy (up to 90 days post surgery)

Results and safety

Results posted to the registry on 4 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intraoperative Data Collection Arm	19	19

Primary outcome: Number of Women Consenting to Have Mastectomy Flap Temperatures Measured During Surgery

Time frame: 90 days post surgery. Count of participants. Unit: Participants

Measure	Intraoperative Data Collection Arm n = 22
Value	19

Population analysed: 22 eligible women were approached to participate, 19 agreed to participate in the study

Primary outcome: Number of Women Having All Relevant Flap Temperatures Measured

Time frame: 90 days post surgery. Count of participants. Unit: Participants

Measure	Intraoperative Data Collection Arm n = 19
Value	15

Population analysed: Temperature measurements were only obtained for 15 of the participants in the study.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Participants will be followed for 90 days after surgery for adverse events. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intraoperative Data Collection Arm	0 of 19 (0%)	0 of 19 (0%)	0 of 19

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

Adam Katz, MD principal investigator

Wake Forest Baptist Health Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Myocardial Probe Temperature Screen and Data Collection in people with Breast Cancer and Mastectomy, run by Wake Forest University Health Sciences at 1 site in United States.

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 0 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: stopped early, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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?

Yes. Results are posted in the registry (first posted 4 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Women Consenting to Have Mastectomy Flap Temperatures Measured During Surgery (time frame: 90 days post surgery). The study lists 2 primary outcomes in all. 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 NCT05395936.

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 4 Dec 2024.