ClinicalTrials.gg
RecruitingNCT06903468Updated Sep 9, 2026

Novel Cavity Marking Technique in Breast Cancer Patients Undergoing Breast Conservation Surgery With Oncoplastic Reconstruction for the Delivery of Adjuvant Radiotherapy and Accuracy of Recommended Re-excisions

An interventional study of Novel cavity marking technique in Ductal Carcinoma in Situ and Breast Cancer, sponsored by University of Florida. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by University of Florida · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2025; still recruiting 1 year later.

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 210 studies in Carcinoma, Intraductal, Noninfiltrating with a site in United States — 31 open to participants now, 51 under way, 6 of them phase 3. Carcinoma, Intraductal, Noninfiltrating · United States.

Planned enrollment
87th of 171
50 · median 51
Started
2025
with 6 others
No phase
65 of 210
11 open now
Primary completion
2027-11
later than 31 of 50 live
Registered
203rd of 210
by date

Among the 210 studies in Carcinoma, Intraductal, Noninfiltrating with a site in United States, this one is the 87th largest by planned enrollment of the 171 interventional ones that give a count, is one of 7 that started in 2025, is one of 65 with no phase, reaches primary completion later than 31 of the 50 other live ones, and was the 203rd registered.

Carcinoma, Intraductal, Noninfiltrating

286 studies on the registry are indexed under Carcinoma, Intraductal, Noninfiltrating; 55 are open to participants now.

Browse Carcinoma, Intraductal, Noninfiltrating studies →

Open to participants now

31 of the 210 studies in Carcinoma, Intraductal, Noninfiltrating with a site in United States are open now. Recruiting first, the newest first:

25 more — sign in →

All 31 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 42 Carcinoma, Intraductal, Noninfiltrating studies recruiting now, 33 (79%) set no upper age limit and 5 (12%) stop at 75 or younger; 1 takes children under 18; 4 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 210 studies in Carcinoma, Intraductal, Noninfiltrating with a site in United States, or all of them as a file.
02

Study summary

This study will investigate a novel approach to marking surgical cavity margins following tumor resection, to allow for more accurate radiotherapy following oncoplastic surgery. Our proposed cavity marking schema will allow radiation oncology to identify the cavity margins more accurately on CT simulation for radiation planning and delivery. This cavity marking schema also provides more accurate margin identification in patients recommended for re-excision of close or positive margins.

03

Conditions studied

  • Ductal Carcinoma in Situ
  • Breast Cancer

Keywords

  • invasive breast cancer
  • non-invasive ductal carcinoma in-situ
  • oncoplastic reconstruction
  • breast conservation surgery
  • boost volume
  • cavity marking
  • breast
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults ≥ 18 years of age.
  • A pathological diagnosis consistent with non-invasive ductal carcinoma in-situ (DCIS) and invasive breast cancer, Tis-T3N0-3M0
  • Subject is planning to undergo or has undergone breast conservation surgery and oncoplastic reconstruction with cavity marking surgery.
  • Performance status of 0-1
  • Written obtained from the subject and the subject agrees to comply with all the study-related procedures.
  • Subjects must not have more than one active at the time of enrollment (Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the regimen [as determined by the treating physician or approved by the PI] may be included).
  • Subjects of (SOCBP) must be using an adequate method of to avoid pregnancy during surgery and radiation therapy. Prior to study enrollment, subjects of childbearing potential must be advised of the importance of avoiding pregnancy during the surgery and radiation portions of the trial and the potential risk factors for an unintentional pregnancy. SOCBP includes any subject who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or who is not . Post-menopause is defined as amenorrhea that has lasted for ≥ 12 consecutive months without another cause.

Exclusion criteria

Exclusion Criteria:

  • Patient not recommended for, or have declined, radiotherapy
  • Subjects with prior ipsilateral breast surgery and identifiable surgical clips.
  • Subjects who are confirmed to be pregnant or breastfeeding.
  • History of any other disease, metabolic dysfunction, clinical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician.
  • Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detailed for treatment of either a psychiatric or physical illness.
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Novel cavity marking technique during breast conservation surgery with oncoplastic reconstruction

    Procedure: Novel cavity marking technique

Interventions

  • ProcedureNovel cavity marking technique

    A novel cavity marking technique will be performed on all participants during their breast conservation surgery. For this technique, cavity marking will be in a clockwise fashion per breast starting with the superior margin of the tumor bed. The superior margin of the left breast will be marked with a single large clip, followed by a double clip for the lateral margin, a triple clip for the inferior margin, and a quadruple clip for the medial margin. The superior margin of the right breast will be marked with a single large clip, followed by a double clip for the medial margin, a triple clip for the inferior margin and a quadruple clip for the lateral margin. Margins with multiple clips will always have one large clip with the remaining clips standard medium size.

06

What researchers measure

Primary outcomes

  1. Confidence rating in cavity identification

    Determine the percentage of patients that receive each of three possible confidence ratings ("Confident", "Informative", and "Ambiguous") from radiation oncologists for their confidence in being able to identify the surgical cavity on imaging.

    Time frame: Within 8 weeks of surgery if patient does not receive adjuvant chemotherapy or within 8 weeks following adjuvant chemotherapy (~4-6 months after surgery

Secondary outcomes

  1. Percent of patients needing re-excision

    Determine the percentage of patients needing re-excision

    Time frame: 7-14 days post-surgery

  2. Local disease recurrence rate

    Determine the percentage of patients that have local disease recurrence at 2 years post-surgery

    Time frame: 2 years post-surgery

  3. Median overall survival rate

    Determine the median overall survival rate at 2 years post-surgery.

    Time frame: 2 years post-surgery

  4. Median recurrence-free survival rate

    Determine the median recurrence-free survival rate at 2 years post-surgery.

    Time frame: 2 years post-surgery

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2025 (actual). Primary completion is estimated for Nov 2027, 25 months after the start.

Of 44 non-industry interventional studies with no phase under Carcinoma, Intraductal, Noninfiltrating, half reached primary completion within 69 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 148. This study's planned 25 months is below that.

Counting every sponsor, half of 47 studies reached it within 69 months; a quarter within 30 and three quarters within 134.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 24, 2025
First posted
Mar 30, 2025
StartActual
Oct 27, 2025
Primary completionEst.
Nov 2027
CompletionEst.
Nov 2029
Last update
Sep 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06903468
Responsible party
Sponsor
First posted
Mar 30, 2025
Start date
Oct 27, 2025
Primary completion
Nov 2027 (estimated)
Completion
Nov 2029 (estimated)
Last update
Sep 9, 2026

Study contacts

Madeline Campellone
Contact
mcampellone@ufl.edu
352-273-5128
Laura J Mallinson
Contact
coppola@ufl.edu
(352) 265-5125
Lisa Spiguel, MD
principal investigator · University of Florida

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion