Invasive Ductal Carcinoma, BreastNCT03523299
Pilot Study to Define the Immune Response Following Cryoablation of Invasive Breast Cancer
A study testing Cryoablation in people with Invasive Ductal Carcinoma, Breast, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
Trial summary
This study will investigate the safety, feasibility, and immune response associated with cryoablation of early invasive breast cancer prior to lumpectomy. Based on mouse models, the investigators believe that cryoablation will initiate a stronger immune response relative to the control group. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Invasive Ductal Carcinoma, Breast
- What is being tested?
- Cryoablation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 22 May 2018to 1 Aug 2019
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ultrasound visible invasive ductal carcinoma (IDC) diagnosed by core needle biopsy;
- Tumor visible by ultrasound at time of treatment;
- Unifocal primary disease;
- Tumor size between 0.5 cm and 2.0 cm (as measured on ultrasound);
- Tumor depth ≥ 0.5 cm from the skin or nipple-areola complex;
- Planned lumpectomy
Who cannot join
- Pregnant patients
- Multifocal or metastatic disease
- Planned neoadjuvant chemotherapy or radiation
- Extensive ductal carcinoma in situ (DCIS; >25% DCIS component) either diagnosed on core biopsy or strongly suggested by imaging
- Known allergy to both lidocaine and benzocaine
About this study
This study will investigate the safety, feasibility, and immune response associated with cryoablation of early invasive breast cancer prior to lumpectomy. Based on mouse models, the investigators believe that cryoablation will initiate a stronger immune response relative to the control group.
Consenting patients will be randomized to one of two arms: standard of care (control) or cryoablation (intervention). Participants will undergo a blood draw at the time of consent. Those in the control arm will continue with their standard of care lumpectomy. The intervention arm will receive cryoablation 2 weeks before their scheduled lumpectomy and undergo a second blood draw before the lumpectomy.
- Conditions
- Invasive Ductal Carcinoma, Breast
- Being tested
- Cryoablation
- Keywords
- invasive ductal carcinoma, breast cancer, cryoablation
- Medical subject headings
- Carcinoma, Ductal, Breast, Breast Neoplasms
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, cryotherapy
Cryoablation is a non-surgical, minimally invasive freezing procedure used to destroy tumors. In the breast, cryoablation is performed under ultrasound guidance. Due to the analgesic properties of freezing, no IV sedation or anesthesia is required. After administration of local anesthetic, the physician makes a 2-3 mm incision and inserts needle-like cryoprobes into the tumor, commencing a number of freeze-thaw cycles. Then the probe is removed, pressure is applied to the area, and a bandage is placed. The patient leaves the office without stitches and minimal, if any, pain. Any residual pain after the procedure is routinely treated with over the counter analgesics such as acetaminophen.
| Study group | Role | What they receive |
|---|---|---|
| Cryoablation | Experimental | Participants in this arm will receive cryoablation of their breast tumor two weeks before their routine lumpectomy. They will undergo two blood draws: one before cryoablation (at the time of consent) and one after cryoablation (at the time of surgery). Receives: Procedure: Cryoablation |
| Control | No intervention | Participants in this arm will undergo a blood draw at the time of consent and then will continue with their scheduled lumpectomy (standard of care). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events [safety]
Assessed via phone call with participant and including any participant-reported adverse events, such as pain, bruising, bleeding, swelling, and skin changes
Measured: 1 day after cryoablation
Immune response
Immunohistochemical analysis of biomarkers in blood and resected tissue
Measured: One week after lumpectomy
Cosmetic outcome
Change in appearance based on distortion and volume loss of the breast
Measured: Change from one month to one year after lumpectomy
Tumor margin status [effectiveness]
Assessment of whether excised tumor's margins are positive or negative for cancer, and whether re-excision is required
Measured: 7-10 days after lumpectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start22 May 2018
- Primary completion1 Aug 2019
- Study completion1 Aug 2019
Why it stopped: Principal investigator wishes to revisit design and start a new study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Ductal Carcinoma, BreastStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cesar Santa-Maria, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03523299
- Sponsor's protocol ID
- SIB16134
- Other IDs
- IRB00077843
- Status last verified
- Aug 2019
- First submitted
- 5 Apr 2018
- Last updated
- 21 Aug 2019
- 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 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Define the Immune Response Following Cryoablation of Invasive Breast Cancer
- ClinicalTrials.gov ID
- NCT03523299
- Acronym / sponsor ID
- SIB16134
- Conditions
- Invasive Ductal Carcinoma, Breast
- Keywords
- invasive ductal carcinoma, breast cancer, cryoablation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Principal investigator wishes to revisit design and start a new study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Study start
- 22 May 2018 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 14 May 2018 (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 study will investigate the safety, feasibility, and immune response associated with cryoablation of early invasive breast cancer prior to lumpectomy. Based on mouse models, the investigators believe that cryoablation will initiate a stronger immune response relative to the control group.
Consenting patients will be randomized to one of two arms: standard of care (control) or cryoablation (intervention). Participants will undergo a blood draw at the time of consent. Those in the control arm will continue with their standard of care lumpectomy. The intervention arm will receive cryoablation 2 weeks before their scheduled lumpectomy and undergo a second blood draw before the lumpectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryoablation | Experimental | Procedure: CryoablationParticipants in this arm will receive cryoablation of their breast tumor two weeks before their routine lumpectomy. They will undergo two blood draws: one before cryoablation (at the time of consent) and one after cryoablation (at the time of surgery). |
| Control | No intervention | –Participants in this arm will undergo a blood draw at the time of consent and then will continue with their scheduled lumpectomy (standard of care). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ultrasound visible invasive ductal carcinoma (IDC) diagnosed by core needle biopsy;
- Tumor visible by ultrasound at time of treatment;
- Unifocal primary disease;
- Tumor size between 0.5 cm and 2.0 cm (as measured on ultrasound);
- Tumor depth ≥ 0.5 cm from the skin or nipple-areola complex;
Key exclusion criteria (5 listed)
- Pregnant patients
- Multifocal or metastatic disease
- Planned neoadjuvant chemotherapy or radiation
- Extensive ductal carcinoma in situ (DCIS; >25% DCIS component) either diagnosed on core biopsy or strongly suggested by imaging
- Known allergy to both lidocaine and benzocaine
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: cryosurgery, cryotherapyCryoablation is a non-surgical, minimally invasive freezing procedure used to destroy tumors. In the breast, cryoablation is performed under ultrasound guidance. Due to the analgesic properties of freezing, no IV sedation or anesthesia is required. After administration of local anesthetic, the physician makes a 2-3 mm incision and inserts needle-like cryoprobes into the tumor, commencing a number of freeze-thaw cycles. Then the probe is removed, pressure is applied to the area, and a bandage is placed. The patient leaves the office without stitches and minimal, if any, pain. Any residual pain after the procedure is routinely treated with over the counter analgesics such as acetaminophen. | Procedure or surgery | Cryoablation |
Primary outcome
Incidence of treatment-emergent adverse events [safety]
Time frame: 1 day after cryoablation
Assessed via phone call with participant and including any participant-reported adverse events, such as pain, bruising, bleeding, swelling, and skin changes
Immune response
Time frame: One week after lumpectomy
Immunohistochemical analysis of biomarkers in blood and resected tissue
Cosmetic outcome
Time frame: Change from one month to one year after lumpectomy
Change in appearance based on distortion and volume loss of the breast
Tumor margin status [effectiveness]
Time frame: 7-10 days after lumpectomy
Assessment of whether excised tumor's margins are positive or negative for cancer, and whether re-excision is required
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 21 Aug 2019.
- 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.
Cesar Santa-Maria, MD principal investigator
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
A study testing Cryoablation in people with Invasive Ductal Carcinoma, Breast, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
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 6 inclusion and 5 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 21 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Incidence of treatment-emergent adverse events [safety] (time frame: 1 day after cryoablation). The study lists 4 primary outcomes in all. 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 2019.