Ductal Carcinoma in SituNCT05032079
Subzero and Scorpion Trial
A study testing cryoablation in people with Ductal Carcinoma in Situ, run by Larkin Community Hospital at 2 sites in United States.
Trial summary
This is a prospective single-institution pilot study examining the feasibility of performing ultrasound-guided cryoablation to completely ablate breast ductal carcinoma in situ (DCIS). The study is designed such that patients meeting selection criteria will undergo cryoablation followed by surgical resection. Read more about this study
- Who is it for?
- Ages 18 to 95 years, women only
- Conditions the study is for
- Ductal Carcinoma in Situ
- What is being tested?
- cryoablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Nov 2020to 1 Sep 2023
- 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 95 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 18
- Pre-registration core biopsy:
- Unifocal primary ductal carcinoma in situ (DCIS) or atypical ductal hyperplasia (ADH) bordering on DCIS or DCIS with microinvasion diagnosed by core needle biopsy. NOTE: Patients with lobular carcinoma, multifocal and/or multicentric ipsilateral breast cancer are NOT eligible. Patients with contralateral disease will remain eligible.
- Tumor size < 1.5 cm in greatest diameter. Specifically, the tumor must measure < 1.5 cm in the axis parallel to the treatment probe and < 1.5 cm in the axis anti-parallel to the treatment probe. Largest size measured by required pre-treatment scans (mammogram, ultrasound and MRI) will be used to determine eligibility.
- An ultrasound visible target for cryoablation:
- Ultrasound-visible mass or nonmass finding corresponding to the tumor or An ultrasound-visible biopsy marker placed within 1cm of the biopsied tumor.
- No prior or planned neoadjuvant chemotherapy for breast cancer.
- Adequate breast size for safe cryoablation. This will be determined by the interventional radiologist using a combination of clinical exam and imaging. Site of target for cryoablation must be greater than 1 cm from the nipple and greater than 1cm from the closest skin surface.
Who cannot join
- Multifocal of multicentric carcinoma.
- Pre-registration core biopsy with diagnosis of frank invasive carcinoma (not microinvasion) or lobular carcinoma.
- Prior or planned neoadjuvant chemotherapy for breast cancer.
- Retroglandular breast implants. (Please note that patients with retropectoral implants are allowed to enroll if they meet all other inclusion criteria.)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Breast Care Center Miami
Miami, Florida, 33173
Diagnostic Center for Women
Miami, Florida, 33173
About this study
Official title: Pilot Study for the Cryoablation of Ductal Carcinoma In Situ: Subzero and Scorpion Trial
This is a prospective single-institution pilot study examining the feasibility of performing ultrasound-guided cryoablation to completely ablate breast ductal carcinoma in situ (DCIS). The study is designed such that patients meeting selection criteria will undergo cryoablation followed by surgical resection. The pathology of the surgical specimen will be used to determine the rate of complete tumor ablation. Standard adjuvant therapies otherwise remained unchanged.
- Conditions
- Ductal Carcinoma in Situ
- Being tested
- cryoablation
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cryoablationProcedure or surgery
Also called cryosurgery
single probe ultrasound guided cryoablation
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Not described Receives: Procedure: cryoablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete tumor ablation
rate of complete tumor ablation defined as no remaining invasive or in situ carcinoma present upon pathological examination of excised tissue
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start16 Nov 2020
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Why it stopped: Study Period Ended / Not Completed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ductal Carcinoma in SituStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Larkin Community Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael J Plaza, MD, Principal investigator, Diagnostic Center for WomenAhkeel Allen, MD, Principal investigator, Breast Care Center Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05032079
- Sponsor's protocol ID
- LCH-112020
- Status last verified
- Oct 2023
- First submitted
- 27 Aug 2021
- Last updated
- 16 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for the Cryoablation of Ductal Carcinoma In Situ: Subzero and Scorpion Trial
- ClinicalTrials.gov ID
- NCT05032079
- Acronym / sponsor ID
- LCH-112020
- Conditions
- Ductal Carcinoma in Situ
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study Period Ended / Not Completed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Larkin Community HospitalUniversity, hospital or other
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 2 Sep 2021 (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.
This is a prospective single-institution pilot study examining the feasibility of performing ultrasound-guided cryoablation to completely ablate breast ductal carcinoma in situ (DCIS). The study is designed such that patients meeting selection criteria will undergo cryoablation followed by surgical resection. The pathology of the surgical specimen will be used to determine the rate of complete tumor ablation. Standard adjuvant therapies otherwise remained unchanged.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Procedure: cryoablation |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age >= 18
- Pre-registration core biopsy:
- Unifocal primary ductal carcinoma in situ (DCIS) or atypical ductal hyperplasia (ADH) bordering on DCIS or DCIS with microinvasion diagnosed by core needle biopsy. NOTE: Patients with lobular carcinoma, multifocal and/or multicentric ipsilateral breast cancer are NOT eligible. Patients with contralateral disease will remain eligible.
- Tumor size < 1.5 cm in greatest diameter. Specifically, the tumor must measure < 1.5 cm in the axis parallel to the treatment probe and < 1.5 cm in the axis anti-parallel to the treatment probe. Largest size measured by required pre-treatment scans (mammogram, ultrasound and MRI) will be used to determine eligibility.
- An ultrasound visible target for cryoablation:
Key exclusion criteria (4 listed)
- Multifocal of multicentric carcinoma.
- Pre-registration core biopsy with diagnosis of frank invasive carcinoma (not microinvasion) or lobular carcinoma.
- Prior or planned neoadjuvant chemotherapy for breast cancer.
- Retroglandular breast implants. (Please note that patients with retropectoral implants are allowed to enroll if they meet all other inclusion criteria.)
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 |
|---|---|---|
| cryoablationAlso: cryosurgerysingle probe ultrasound guided cryoablation | Procedure or surgery | Treatment Arm |
Primary outcome
complete tumor ablation
Time frame: 2 years
rate of complete tumor ablation defined as no remaining invasive or in situ carcinoma present upon pathological examination of excised tissue
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2023.
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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.
Michael J Plaza, MD principal investigator
Diagnostic Center for Women
Ahkeel Allen, MD principal investigator
Breast Care Center Miami
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cryoablation in people with Ductal Carcinoma in Situ, run by Larkin Community Hospital at 2 sites 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 8 inclusion and 4 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: withdrawn, as of the sponsor's last update on 16 Oct 2023. 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
complete tumor ablation (time frame: 2 years). 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 16 Oct 2023; AzTrials last refreshed its copy on 31 Oct 2026.