Breast Cancer FemaleIORT-BreastNCT04595435
IORT-Breast at Medical Center Navicent Health
An observational study of Breast Cancer Female and Early-stage Breast Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Intraoperative Breast Radiation Therapy (IORT-Breast) utilizing the Xoft Axxent Electronic Brachytherapy System (Xoft) has been recently introduced as a treatment option for women 50 years of age and older who have early stage, low risk Invasive Breast Cancer (IBC). Read more about this study
- Who is it for?
- Ages 55 years and older, women only
- Conditions the study is for
- Breast Cancer Female, Early-stage Breast Cancer
- What is being tested?
- Lumpectomy and Intraoperative Radiation Therapy
- Type of treatment
- Surgery or procedure
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2019to 31 Dec 2033
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 55 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated at Navicent Health who meet eligibility criteria for IORT-Breast or who have received IORT-Breast within the previous 6 months
Who may be able to join
- Signed informed consent and HIPAA authorization
- T1 tumor (less than or equal to 20mm in greatest diameter)
- Unifocal
- Histological Grade 1 or 2
- Node Negative
- ER +ve
- HER-2 -ve
Who cannot join
- Previous radiation therapy to the involved breast other than IORT within 6 months
- High grade tumors (Histologic grade 3)
- Her-2 Positive
- Lymphovascular invasion
- Metastatic disease
- close proximity to or involvement of skin
- Multifocal cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical Center, Navicent Health
Macon, Georgia, 31201
About this study
Official title: Prospective Registry of Intraoperative Radiation Therapy Using Low Energy X-ray for Breast Cancer at Medical Center, Navicent Health
Intraoperative Breast Radiation Therapy (IORT-Breast) utilizing the Xoft Axxent Electronic Brachytherapy System (Xoft) has been recently introduced as a treatment option for women 50 years of age and older who have early stage, low risk Invasive Breast Cancer (IBC). Clinical trials have shown IORT to be non-inferior to whole breast radiation, however some concern continues with rates of recurrence and clinical outcomes.
Given the recent introduction and continued debate it is an excellent opportunity to observe and monitor outcomes in the patients that are treated at Navicent Health through this prospective, observational registry. The opportunity also permits examination of the participant's thoughts and feeling on Quality of Life and Cosmetic Appearance
Read the detailed description
Objectives: (primary and important secondary objectives) The primary objective is to determine rates of recurrence at 5, and 10 years following IORT-Breast at Navicent Health.
Secondary objectives include determination of acute and late effects of IORT-Breast at the treatment site, cosmetic outcomes and satisfaction over 10 years.
In addition, the study will determine why patients who were scheduled for IORT-Breast did not receive it after lumpectomy.
Study Design:
Prospective, observational registry.
Setting/Participants:
The study focuses on outpatients/short stay surgery performed at the Medical Center, Navicent Health, Macon, GA only.
Participants have been deemed eligible for IORT-Breast or have received IORT-Breast within the last 6 months. Key eligibility criteria for IORT- Breast includes women, aged 55 years old or greater, diagnosed with clinically node negative, grade 1 or 2 Invasive Breast Cancer with no lymphovascular invasion, that is 20mm or less in greatest dimension, Estrogen Receptor (ER) positive, HER 2 Neu Negative, and with a depth greater than 10mm from skin.
Study Interventions and Measures:
Participants will be eligible for IORT-Breast or have received IORT-Breast in the previous 6 months. Participants who were scheduled for IORT-Breast and do not receive IORT-Breast will have reasons for not receiving IORT-Breast recorded and will not be followed further. Participants receiving IORT-Breast will have treatment parameters recorded and will be followed every 6 months for 2 years and then annually until up to 10 years following treatment.
- Conditions
- Breast Cancer Female, Early-stage Breast Cancer
- Being tested
- Lumpectomy, Intraoperative Radiation Therapy
- Keywords
- Intraoperative Radiation Therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LumpectomyProcedure or surgery
Also called Breast Conserving Surgery
Removal of lump/tumor from breast utilizing an approach that saves as much breast as possible.
Intraoperative Radiation TherapyRadiation
Also called IORT
Delivery of low energy radiation therapy directly at surgical site, immediately removal of lump and tissue prior to final surgical closure
| Study group | Role | What they receive |
|---|---|---|
| Cohort A- Preoperative Prospective | Subjects are eligible to receive IORT and have agreed to participate in the study prior to any intervention. Receives: Procedure: Lumpectomy; Radiation: Intraoperative Radiation Therapy | |
| Cohort B- Postoperative Prospective | Subjects who have had IORT performed within the previous 6 month who agree to participate. Receives: Procedure: Lumpectomy; Radiation: Intraoperative Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of recurrence
To determine rate of recurrence of disease at specific time period
Measured: 5 year
Rate of recurrence
To determine rate of recurrence of disease at specific time period
Measured: 10 year
Secondary outcomes (2)
Acute and late effects
To determine the rate of acute and late effects of IORT at the treatment site. Periodic review by surgeon and self reports identifying acute and late effects and calculating the rate of incidence for the treated group.
Measured: 5 years
Treatment Abandonment
To determine rate and reason for abandoning procedure after being scheduled for procedure. Calculating the rate of those who were scheduled to receive IORT and then did not receive the treatment as planned and reason why they did not receive the treatment.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start19 Mar 2019
- Primary completion31 Dec 2033 (estimated)
- Study completion31 Dec 2033 (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 Wake Forest University Health SciencesThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 94 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Atrium Health Navicent
- Responsible party
- Sponsor
- Investigators
- Paul Dale, MD, Principal investigator, Atrium Health Navicent Physician's GroupDavid Cole, MD, Principal investigator, Central Georgia Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04595435
- Sponsor's protocol ID
- IRB00092014
- Other IDs
- H1901940, IORT
- Acronym
- IORT-Breast
- Status last verified
- Jul 2026
- First submitted
- 8 Apr 2019
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Registry of Intraoperative Radiation Therapy Using Low Energy X-ray for Breast Cancer at Medical Center, Navicent Health
- ClinicalTrials.gov ID
- NCT04595435
- Acronym / sponsor ID
- IORT-Breast / IRB00092014
- Conditions
- Breast Cancer Female, Early-stage Breast Cancer
- Keywords
- Intraoperative Radiation Therapy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Atrium Health Navicent
- Study start
- 19 Mar 2019 (actual)
- Primary completion
- 31 Dec 2033 (estimated)
- Study completion
- 31 Dec 2033 (estimated)
- First posted
- 20 Oct 2020 (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.
Intraoperative Breast Radiation Therapy (IORT-Breast) utilizing the Xoft Axxent Electronic Brachytherapy System (Xoft) has been recently introduced as a treatment option for women 50 years of age and older who have early stage, low risk Invasive Breast Cancer (IBC). Clinical trials have shown IORT to be non-inferior to whole breast radiation, however some concern continues with rates of recurrence and clinical outcomes.
Given the recent introduction and continued debate it is an excellent opportunity to observe and monitor outcomes in the patients that are treated at Navicent Health through this prospective, observational registry. The opportunity also permits examination of the participant's thoughts and feeling on Quality of Life and Cosmetic Appearance
Detailed description
Objectives: (primary and important secondary objectives) The primary objective is to determine rates of recurrence at 5, and 10 years following IORT-Breast at Navicent Health.
Secondary objectives include determination of acute and late effects of IORT-Breast at the treatment site, cosmetic outcomes and satisfaction over 10 years.
In addition, the study will determine why patients who were scheduled for IORT-Breast did not receive it after lumpectomy.
Study Design:
Prospective, observational registry.
Setting/Participants:
The study focuses on outpatients/short stay surgery performed at the Medical Center, Navicent Health, Macon, GA only.
Participants have been deemed eligible for IORT-Breast or have received IORT-Breast within the last 6 months. Key eligibility criteria for IORT- Breast includes women, aged 55 years old or greater, diagnosed with clinically node negative, grade 1 or 2 Invasive Breast Cancer with no lymphovascular invasion, that is 20mm or less in greatest dimension, Estrogen Receptor (ER) positive, HER 2 Neu Negative, and with a depth greater than 10mm from skin.
Study Interventions and Measures:
Participants will be eligible for IORT-Breast or have received IORT-Breast in the previous 6 months. Participants who were scheduled for IORT-Breast and do not receive IORT-Breast will have reasons for not receiving IORT-Breast recorded and will not be followed further. Participants receiving IORT-Breast will have treatment parameters recorded and will be followed every 6 months for 2 years and then annually until up to 10 years following treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A- Preoperative Prospective | – | Procedure: Lumpectomy, Radiation: Intraoperative Radiation TherapySubjects are eligible to receive IORT and have agreed to participate in the study prior to any intervention. |
| Cohort B- Postoperative Prospective | – | Procedure: Lumpectomy, Radiation: Intraoperative Radiation TherapySubjects who have had IORT performed within the previous 6 month who agree to participate. |
Who may qualify
- Ages
- 55 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated at Navicent Health who meet eligibility criteria for IORT-Breast or who have received IORT-Breast within the previous 6 months
Key inclusion criteria (7 listed)
- Signed informed consent and HIPAA authorization
- T1 tumor (less than or equal to 20mm in greatest diameter)
- Unifocal
- Histological Grade 1 or 2
- Node Negative
Key exclusion criteria (7 listed)
- Previous radiation therapy to the involved breast other than IORT within 6 months
- High grade tumors (Histologic grade 3)
- Her-2 Positive
- Lymphovascular invasion
- Metastatic disease
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 |
|---|---|---|
| LumpectomyAlso: Breast Conserving SurgeryRemoval of lump/tumor from breast utilizing an approach that saves as much breast as possible. | Procedure or surgery | Cohort A- Preoperative Prospective, Cohort B- Postoperative Prospective |
| Intraoperative Radiation TherapyAlso: IORTDelivery of low energy radiation therapy directly at surgical site, immediately removal of lump and tissue prior to final surgical closure | Radiation | Cohort A- Preoperative Prospective, Cohort B- Postoperative Prospective |
Primary outcome
Rate of recurrence
Time frame: 5 year
To determine rate of recurrence of disease at specific time period
Rate of recurrence
Time frame: 10 year
To determine rate of recurrence of disease at specific time period
2 secondary outcomes
Acute and late effects
Time frame: 5 years
Treatment Abandonment
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
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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.
Paul Dale, MD principal investigator
Atrium Health Navicent Physician's Group
David Cole, MD principal investigator
Central Georgia Radiation Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Female and Early-stage Breast Cancer, run by Wake Forest University Health Sciences 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 7 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 23 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Rate of recurrence (time frame: 5 year). The study lists 2 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 23 Jul 2026.