Ductal Breast Carcinoma in SituNCT01791998
Magnetic Resonance Thermal Image Guided Laser Interstitial Thermal Therapy in Treating Patients With Breast Cancer
A study testing magnetic resonance thermal imaging and laser interstitial thermal therapy in people with Ductal Breast Carcinoma in Situ and Invasive Ductal Breast Carcinoma, run by University of Chicago at 1 site in United States.
Trial summary
This pilot clinical trial studies magnetic resonance thermal image guided laser interstitial thermal therapy in treating patients with breast cancer. Magnetic resonance thermal image guided laser interstitial thermal therapy may be able to kill tumor cells by heating up the tumor cells without affecting the… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Ductal Breast Carcinoma in Situ, Invasive Ductal Breast Carcinoma, Stage IA Breast Cancer
- What is being tested?
- magnetic resonance thermal imaging and laser interstitial thermal therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Jun 2014
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Postmenopausal state
- Histological diagnosis of breast invasive ductal carcinoma with receptor profiles obtained
- MRI visible breast lesion
- Unifocal cancer, less than 1.5 cm in maximum diameter (clinical stage T1), with no evidence of extensive in situ cancer surrounding the main tumor; the eligibility will be determined by the MR imaging appearance of the tumor; if the tumor (proven invasive ductal carcinoma) is a unifocal mass without additional enhancement, it will be judged eligible; however, if the tumor is associated with additional enhancement and/or a satellite focus, it will not judged ineligible, as these are signs of additional in situ or invasive cancer
- Clinical stage N0 (no metastatic axillary lymph node on physical examination or imaging work-up)
- Ability to give informed consent
Who cannot join
- Previous surgery or radiation for the ipsilateral breast cancer
- Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI
- Tumor located less than 1 cm from the skin or the pectoralis muscle
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637-1470
About this study
Official title: A Pilot Study to Evaluate Magnet Resonance Thermal Imageguided Interstital Thermal Therapy for Focal Ablation of Breast Cancer
This pilot clinical trial studies magnetic resonance thermal image guided laser interstitial thermal therapy in treating patients with breast cancer. Magnetic resonance thermal image guided laser interstitial thermal therapy may be able to kill tumor cells by heating up the tumor cells without affecting the surrounding tissue
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the procedural success rate of using the Visualase magnetic resonance (MR)-guided laser system to target, access, thermally monitor, and focally ablate MR-visible breast cancer lesions.
- To obtain preliminary data on ablative success using pathologic assessment for specimen excised subsequent to the ablation.
OUTLINE:
Patients undergo MR-thermal image guided laser interstitial thermal therapy (LITT) over 1 hour.
After completion of study treatment, patients are followed up at 3-7 days.
- Conditions
- Ductal Breast Carcinoma in Situ, Invasive Ductal Breast Carcinoma, Stage IA Breast Cancer, Stage IB Breast Cancer
- Being tested
- magnetic resonance thermal imaging, laser interstitial thermal therapy
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating, Carcinoma, Ductal, Breast, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic resonance thermal imagingProcedure or surgery
Undergo MR-thermal image guided LITT
laser interstitial thermal therapyProcedure or surgery
Undergo MR-thermal image guided LITT
| Study group | Role | What they receive |
|---|---|---|
| Treatment (MR-thermal image guided LITT) | Experimental | Patients undergo MR-thermal image guided LITT over 1 hour. Receives: Procedure: magnetic resonance thermal imaging; Procedure: laser interstitial thermal therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of not completing the procedure due to patient's discomfort
Measured: Up to 7 days
Observed thermal damage on skin
Moderate degree of skin burn which requires medical intervention will be considered side effects for stopping purposes.
Measured: Up to 7 days
Grade 3 or 4 toxicities assessed by the National Cancer Institute (NCI) Common Toxicity Criteria (CTC)
Measured: Up to 7 days
Secondary outcomes (2)
Amount of tumor necrosis
Measured: Up to 7 days
Amount of viable tumor
Measured: Up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startAug 2012
- Primary completionJun 2014
- Study completionJun 2014
Why it stopped: Funding was time sensitive and expired. No subjects enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ductal Breast Carcinoma in SituStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Hiroyuki Abe, Principal investigator, University of Chicago Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01791998
- Sponsor's protocol ID
- 12-1017
- Other IDs
- NCI-2013-00066
- Status last verified
- Oct 2014
- First submitted
- 12 Feb 2013
- Last updated
- 15 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate Magnet Resonance Thermal Imageguided Interstital Thermal Therapy for Focal Ablation of Breast Cancer
- ClinicalTrials.gov ID
- NCT01791998
- Acronym / sponsor ID
- 12-1017
- Conditions
- Ductal Breast Carcinoma in Situ, Invasive Ductal Breast Carcinoma, Stage IA Breast Cancer, Stage IB Breast Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding was time sensitive and expired. No subjects enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 15 Feb 2013 (estimated)
- 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 pilot clinical trial studies magnetic resonance thermal image guided laser interstitial thermal therapy in treating patients with breast cancer. Magnetic resonance thermal image guided laser interstitial thermal therapy may be able to kill tumor cells by heating up the tumor cells without affecting the surrounding tissue
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the procedural success rate of using the Visualase magnetic resonance (MR)-guided laser system to target, access, thermally monitor, and focally ablate MR-visible breast cancer lesions.
- To obtain preliminary data on ablative success using pathologic assessment for specimen excised subsequent to the ablation.
OUTLINE:
Patients undergo MR-thermal image guided laser interstitial thermal therapy (LITT) over 1 hour.
After completion of study treatment, patients are followed up at 3-7 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (MR-thermal image guided LITT) | Experimental | Procedure: magnetic resonance thermal imaging, Procedure: laser interstitial thermal therapyPatients undergo MR-thermal image guided LITT over 1 hour. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Postmenopausal state
- Histological diagnosis of breast invasive ductal carcinoma with receptor profiles obtained
- MRI visible breast lesion
- Unifocal cancer, less than 1.5 cm in maximum diameter (clinical stage T1), with no evidence of extensive in situ cancer surrounding the main tumor; the eligibility will be determined by the MR imaging appearance of the tumor; if the tumor (proven invasive ductal carcinoma) is a unifocal mass without additional enhancement, it will be judged eligible; however, if the tumor is associated with additional enhancement and/or a satellite focus, it will not judged ineligible, as these are signs of additional in situ or invasive cancer
- Clinical stage N0 (no metastatic axillary lymph node on physical examination or imaging work-up)
Key exclusion criteria (3 listed)
- Previous surgery or radiation for the ipsilateral breast cancer
- Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI
- Tumor located less than 1 cm from the skin or the pectoralis muscle
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 |
|---|---|---|
| magnetic resonance thermal imagingUndergo MR-thermal image guided LITT | Procedure or surgery | Treatment (MR-thermal image guided LITT) |
| laser interstitial thermal therapyUndergo MR-thermal image guided LITT | Procedure or surgery | Treatment (MR-thermal image guided LITT) |
Primary outcome
Frequency of not completing the procedure due to patient's discomfort
Time frame: Up to 7 days
Observed thermal damage on skin
Time frame: Up to 7 days
Moderate degree of skin burn which requires medical intervention will be considered side effects for stopping purposes.
Grade 3 or 4 toxicities assessed by the National Cancer Institute (NCI) Common Toxicity Criteria (CTC)
Time frame: Up to 7 days
2 secondary outcomes
Amount of tumor necrosis
Time frame: Up to 7 days
Amount of viable tumor
Time frame: Up to 7 days
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 15 Oct 2014.
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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.
Hiroyuki Abe principal investigator
University of Chicago Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing magnetic resonance thermal imaging and laser interstitial thermal therapy in people with Ductal Breast Carcinoma in Situ and Invasive Ductal Breast Carcinoma, run by University of Chicago 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 6 inclusion and 3 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 15 Oct 2014. 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?
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?
Frequency of not completing the procedure due to patient's discomfort (time frame: Up to 7 days). The study lists 3 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 15 Oct 2014.