Breast Cancer FemaleNCT06635096
The Safety and Efficacy of Multimodal Thermal Therapy in the Treatment of Early-stage Invasive Breast Cancer
A study testing Multimodal Tumor Thermal Therapy System (Shanghai MAaGI Medical Technology Co., Ltd.) in people with Breast Cancer Female, run by Fudan University at 1 site in China.
Trial summary
Multimodal thermal therapy (MTT), as an initiative integration of cryotherapy and radiofrequency heating, has been applied to treat various solid tumors. However, the feasibility and safety for MTT in the treatment of breast cancer is unknown. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- Multimodal Tumor Thermal Therapy System (Shanghai MAaGI Medical Technology Co., Ltd.)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 8 Oct 2024to 7 Oct 2026
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female，age 18-80 years.
- Invasive carcinoma confirmed by core biopsy.
- Newly diagnosed breast cancer patients, without neoadjuvant therapy.
- Imaging findings showed an unifocal breast tumor with a maximum diameter of 2 cm, with no distant metastasis, no calcification, no skin or nipple adhesion, and no invasion of chest wall.
- The functional level of major organs must meet the following requirements: blood routine: neutrophil (ANC)≥1.5×10^9/L; platelet count (PLT) ≥ (PLT)≥90×10^9/L; hemoglobin (Hb) ≥90g/L; coagulation: international normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN; activated partial thromboplastin time (APTT) ≤1.5×ULN.
Who cannot join
- Tumor involving skin, ulceration, inflammatory breast cancer patients.
- Tumor involving the superficial layer of the skin.
- KPS score < 70, or ECOG score > 2
- Prior radiotherapy or prior use of investigational drugs or other immunosuppressive agents.
- Heart, brain, lung, kidney and other vital organ failure.
- Uncorrectable severe coagulopathy
Show all 12Show fewer
- Patient is pregnant or lactating
- Poor glycemic control in diabetes
- Patients with foreign body implantation around the tumor (such as breast augmentation injections or prostheses).
- Patients with severe scars on the skin of the treatment area (protruding from the skin surface, width ≥ 1 cm)
- Human immunodeficiency virus (HIV) infection, active hepatitis B (hepatitis B indicates antigen positive and HBV DNA ≥ 500 IU/ml), hepatitis C (hepatitis C antibody positive and HCV-RNA above the lower limit of detection of the analytical method).
- Concurrent medical conditions that, in the judgment of the investigator, would jeopardize the subject's safety, could confound the study results, or affect the subject's completion of this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Breast cancer institute of Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, 200032
Zhimin Shao, M.D, 86-21-64175590, zhimingshao@yahoo.com
About this study
Official title: A Prospective, Single-center, Single-arm Phase II Clinical Trial to Evaluate the Safety and Efficacy of Multimodal Thermal Therapy in the Treatment of Early-stage Invasive Breast Cancer
Multimodal thermal therapy (MTT), as an initiative integration of cryotherapy and radiofrequency heating, has been applied to treat various solid tumors. However, the feasibility and safety for MTT in the treatment of breast cancer is unknown. This prospective, open-label, single-arm phase II clinical study aimed to evaluate the efficacy and safety of MTT in the treatment of early-stage invasive breast cancer, and to explore the ablation-induced immune activating response.
- Conditions
- Breast Cancer Female
- Being tested
- Multimodal Tumor Thermal Therapy System (Shanghai MAaGI Medical Technology Co., Ltd.)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal Tumor Thermal Therapy System (Shanghai MAaGI Medical Technology Co., Ltd.)Device
These patients will receive multimodal thermal therapy using Multimodal Tumor Thermal Therapy System.
| Study group | Role | What they receive |
|---|---|---|
| Multimodal Thermal Therapy alone | Experimental | Multimodal Thermal Therapy Receives: Device: Multimodal Tumor Thermal Therapy System (Shanghai MAaGI Medical Technology Co., Ltd.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete ablation rate
The complete ablation rate was confirmed by core needle biopsy 3 months after multimodal thermal therapy. Complete ablation was defined as: tissue section at the ablation margin that was negative by histochemical staining.
Measured: 3 months
Secondary outcomes (4)
Safety of Multimodal Tumor Thermal Therapy
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 5.0.
Measured: In 1 year
Breast MRI confirmed complete ablation.
According to the mRECIST criteria, the complete ablation was confirmed by breast MRI in 6 months after multimodal thermal therapy.
Measured: In 6 months
Breast self evaluation
Breast self evaluation for patients will be assessed by Functional Assessment of Cancer Therapy - Breast (FACT-B) scale scores.The FACT-B consists of 44 self-report items and assesses the specific breast cancer-related quality of life on 4 general and 1 breast-cancer specific subscale. A higher score indicates a higher cancer-related quality of life.
Measured: In 1 year
Assessment of immune activating response
Immune indicator analysis will be conducted to evaluate the immune status and response of participants to the intervention. This will include the assessment of various immune cell populations and markers, such as:
- CD4+ and CD8+ T lymphocyte counts and ratios.
- B cell counts and subsets.
- Dendritic cell (DC) counts and functionality.
- Monocyte counts and subsets.
Measured: In 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start8 Oct 2024 (estimated)
- Primary completion7 Mar 2026 (estimated)
- Study completion7 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhimin Shao, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06635096
- Sponsor's protocol ID
- MTT-BC-001
- Status last verified
- Oct 2024
- First submitted
- 25 Sep 2024
- Last updated
- 10 Oct 2024
- 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 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-center, Single-arm Phase II Clinical Trial to Evaluate the Safety and Efficacy of Multimodal Thermal Therapy in the Treatment of Early-stage Invasive Breast Cancer
- ClinicalTrials.gov ID
- NCT06635096
- Acronym / sponsor ID
- MTT-BC-001
- Conditions
- Breast Cancer Female
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 8 Oct 2024 (estimated)
- Primary completion
- 7 Mar 2026 (estimated)
- Study completion
- 7 Oct 2026 (estimated)
- First posted
- 10 Oct 2024 (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.
Multimodal thermal therapy (MTT), as an initiative integration of cryotherapy and radiofrequency heating, has been applied to treat various solid tumors. However, the feasibility and safety for MTT in the treatment of breast cancer is unknown. This prospective, open-label, single-arm phase II clinical study aimed to evaluate the efficacy and safety of MTT in the treatment of early-stage invasive breast cancer, and to explore the ablation-induced immune activating response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multimodal Thermal Therapy alone | Experimental | Device: Multimodal Tumor Thermal Therapy System (Shanghai MAaGI Medical Technology Co., Ltd.)Multimodal Thermal Therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female，age 18-80 years.
- Invasive carcinoma confirmed by core biopsy.
- Newly diagnosed breast cancer patients, without neoadjuvant therapy.
- Imaging findings showed an unifocal breast tumor with a maximum diameter of 2 cm, with no distant metastasis, no calcification, no skin or nipple adhesion, and no invasion of chest wall.
- The functional level of major organs must meet the following requirements: blood routine: neutrophil (ANC)≥1.5×10^9/L; platelet count (PLT) ≥ (PLT)≥90×10^9/L; hemoglobin (Hb) ≥90g/L; coagulation: international normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN; activated partial thromboplastin time (APTT) ≤1.5×ULN.
Key exclusion criteria (12 listed)
- Tumor involving skin, ulceration, inflammatory breast cancer patients.
- Tumor involving the superficial layer of the skin.
- KPS score < 70, or ECOG score > 2
- Prior radiotherapy or prior use of investigational drugs or other immunosuppressive agents.
- Heart, brain, lung, kidney and other vital organ failure.
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 |
|---|---|---|
| Multimodal Tumor Thermal Therapy System (Shanghai MAaGI Medical Technology Co., Ltd.)These patients will receive multimodal thermal therapy using Multimodal Tumor Thermal Therapy System. | Device | Multimodal Thermal Therapy alone |
Primary outcome
Complete ablation rate
Time frame: 3 months
The complete ablation rate was confirmed by core needle biopsy 3 months after multimodal thermal therapy. Complete ablation was defined as: tissue section at the ablation margin that was negative by histochemical staining.
4 secondary outcomes
Safety of Multimodal Tumor Thermal Therapy
Time frame: In 1 year
Breast MRI confirmed complete ablation.
Time frame: In 6 months
Breast self evaluation
Time frame: In 1 year
Assessment of immune activating response
Time frame: In 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal Tumor Thermal Therapy System (Shanghai MAaGI Medical Technology Co., Ltd.) in people with Breast Cancer Female, run by Fudan University at 1 site in China.
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 5 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 10 Oct 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhimin Shao, M.D (86-021-64175590 ext. 88807, zhimingshao@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete ablation rate (time frame: 3 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 10 Oct 2024.