Breast CancerOMM on SLNBNCT07269860
Impact of Osteopathic Manipulative Medicine on Sentinal Lymph Node Biopsy Dye and Tracer Uptake
A study testing OMM prior to SLNB in people with Breast Cancer, run by University of Arizona at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if osteopathic manipulative medicine (OMM) will allow for more uptake of isosulfan blue dye and radiotracers used in sentinal lymph node biopsy (SLNB) compared to massage alone. SLNB is used to characterize the stage and spread of cancer cells in breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- OMM prior to SLNB
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2025to 30 Oct 2025
- 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 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First time breast cancer patients (female only) undergoing breast conserving surgery (lumpectomy or partial mastectomy) and sentinel lymph node biopsy.
Who cannot join
- Previous breast cancer
- previous axillary surgery
- previous chest wall or axillary radiation
- previous breast surgery
- known axillary disease
- patients undergoing total mastectomies
- Contraindications to OMM include inability to access the axilla due to range of motion, previous shoulder injury or shoulder surgery on the treatment side, fractures or metastatic lesions to the bones on the treatment side, open wounds over the treatment area or underlying abscess/infection, pacemaker on the side of treatment, subclavian vein central line or port.
Trial locations and contacts
1 site in 1 country.
United States1 site
Banner University Medical Center - Tucson
Tucson, Arizona, 85719
About this study
Official title: The Impact of Osteopathic Manipulative Medicine on Radiotracer and Isosulfan Blue Dye Uptake During Breast Conserving Surgery and Sentinel Lymph Node Biopsy.
The goal of this clinical trial is to learn if osteopathic manipulative medicine (OMM) will allow for more uptake of isosulfan blue dye and radiotracers used in sentinal lymph node biopsy (SLNB) compared to massage alone. SLNB is used to characterize the stage and spread of cancer cells in breast cancer patients. The main questions it aims to answer is:
- Does OMM + massage allow for greater uptake of isosulfan blue dye and radiotracer in the lymph nodes compared to current standard of practice of breast massage after isosulfan blue dye and radiotracer injection.
Read more
Researchers will compare OMM + massage to current standard of practice of breast massage.
Randomization: Patients will be randomized prior to surgical intervention as to which arm of the study they will be assigned to: Massage (current standard) vs OMM + Massage
Massage: 9 minutes of circular massage over the nipple areolar complex to disperse isosulfan blue dye and radiotracer that were injected into the breast. Massage following injection is standard of care.
OMM+ Massage: 5 minutes of massage as above and then will perform osteopathic techniques including 1 minute of each of the following: opening the thoracic inlet, pectoral traction, and axillary pump. Thoracic pump will be done for 2 minutes. Isosulfan blue dye and radiotracer will then be injected followed by massage as done in the current standard of practice. The injection and massage are performed as per standard of care.
Read the detailed description
In order to appropriately and adequately treat breast cancer, sentinel lymph node mapping and biopsies are used to characterize stage and spread of cancer cells. Isosulfan blue dye and radiotracers are used to identify and target the sentinel lymph node and, therefore the specific group of lymphatic vessels that are draining the breast cancer. In order to identify the sentinel node, lymphatic vessels must be draining properly to allow for dye or radiotracer to have adequate uptake within the lymphatic system. Lymphatic vessels themselves or the fascia surrounding lymphatic vessels can have innate or pathological dysfunction that can be improved by osteopathic manipulation of these structures allowing for more accurate node identification with blue dye and radiotracer.
This study will look at the impact of osteopathic manipulation on fascia of the anterior chest wall as well as the lymphatic system draining the breast. We will compare the current standard of practice of breast massage after isosulfan blue dye and radiotracer injection to OMM + massage. Qualitative blue dye uptake in the sentinel lymph node as well as target values of radiotracer will be analyzed.
Two main points of data will be collected in order to determine how well the axilla mapped for that operation. These data points are the amount of isosulfan blue dye uptake in the lymph nodes and the target values on the neoprobe that tell how much radio tracer made it to those lymph nodes. The more blue in color a lymph node is and the higher the target value on the neoprobe determines if a node is the sentinel node in a typical breast cancer operation. We will use those same end points to assess if we have better uptake of blue dye or radio tracer in the axilla with or without the addition of OMM. In order to quantify the amount of blue dye uptake in a node, each node removed during the procedure will be categorized under blue or not blue. For those nodes that are blue, they will be analyzed as falling under 100%, 75%, 50%, or 25% blue. Meaning if half of the node is blue and half is a normal tissue color, this node would count under the 50% blue category. All blue nodes are typically removed during a sentinel lymph node operation. The second endpoint is the target value. The neoprobe detects and quantifies the amount of the radiotracer that was previously injected. If a node uptakes the radiotracer, it will be detected with the neoprobe. In a typical sentinel node operation, the nodes with the most tracer signal are removed and the target value (10 second count of the amount of radiotracer) is obtained for that node. Any other node in the axilla that is 10% of that highest target value will also be removed as it has the chance of being the sentinel node. For example if the hottest node in the axilla has a target value of 15000 then any node that is detected to have a value of 1500 or higher via the neoprobe will be removed. All radioactive nodes that fall into this 10% rule will be removed as per the usual surgery protocol and a target value obtained for each node. These values will be recorded as a way to determine how effective the radiotracer uptake was in the axilla.
Hypothesis: OMM + massage will have increased radiotracer target values and more isosulfan blue dye uptake in the sentinel lymph node compared to massage alone.
- Conditions
- Breast Cancer
- Being tested
- OMM prior to SLNB
- Keywords
- Osteopathic Manipulative Medicine, Sentinal lymph node biopsy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMM prior to SLNBProcedure or surgery
Perform osteopathic techniques including 1 minute of each of the following: opening the thoracic inlet, pectoral traction, and axillary pump. Thoracic pump will be done for 2 minutes. Isosulfan blue dye and radiotracer will then be injected followed by massage as done in the current standard of practice. The injection and massage are performed as per standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Massage | No intervention | Patients will receive the standard of care practice for SLNB of 9 minutes of circular massage over the nipple areolar complex to disperse isosulfan blue dye and radiotracer that were injected into the breast. |
| OMM + Massage | Experimental | 5 min of massage plus perform osteopathic techniques including 1 minute of each of the following: opening the thoracic inlet, pectoral traction, and axillary pump. Thoracic pump will be done for 2 minutes. Isosulfan blue dye and radiotracer will then be injected followed by massage as done in the current standard of practice. The injection and massage are performed as per standard of care. Receives: Procedure: OMM prior to SLNB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of isosulfan blue dye uptake in the lymph nodes
In order to quantify the amount of blue dye uptake in a node, each node removed during the procedure will be categorized under blue or not blue. The percentage of blue dye uptake is determined visually by the operating surgeon. All surgeons were trained on how to identify these percentages. A node is labeled as 25% blue if it had a blue channel and/or minimal blue coloration of the node, 50% blue if it is a moderately/partially blue node, 75% blue if it was a mostly blue node, and 100% blue if it was a completely blue node.
Measured: Through study completion, 4 months
Secondary outcomes (1)
Target value of neoprobe that tell how much radiotracer makes it to the lymph nodes
The second endpoint is the target value. The neoprobe detects and quantifies the amount of the radiotracer that was previously injected. If a node uptakes the radiotracer, it will be detected with the neoprobe. In a typical sentinel node operation, the nodes with the most tracer signal are removed and the target value (10 second count of the amount of radiotracer) is obtained for that node. Any other node in the axilla that is 10% of that highest target value will also be removed as it has the chance of being the sentinel node. For example if the hottest node in the axilla has a target value of 15000 then any node that is detected to have a value of 1500 or higher via the neoprobe will be removed. All radioactive nodes that fall into this 10% rule will be removed as per the usual surgery protocol and a target value obtained for each node. These values will be recorded as a way to determine how effective the radiotracer uptake was in the axilla.
Measured: Through study completion, 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start9 Jul 2025
- Primary completion30 Oct 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized in a 1:1 ratio to receive standard of care or intervention.
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- Tucson Osteopathic Medical Foundation
- Responsible party
- Sponsor
- Investigators
- Ivy Stejskal, DO, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07269860
- Sponsor's protocol ID
- STUDY00004477
- Acronym
- OMM on SLNB
- Status last verified
- Nov 2025
- First submitted
- 25 Nov 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Osteopathic Manipulative Medicine on Radiotracer and Isosulfan Blue Dye Uptake During Breast Conserving Surgery and Sentinel Lymph Node Biopsy.
- ClinicalTrials.gov ID
- NCT07269860
- Acronym / sponsor ID
- OMM on SLNB / STUDY00004477
- Conditions
- Breast Cancer
- Keywords
- Osteopathic Manipulative Medicine, Sentinal lymph node biopsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- Tucson Osteopathic Medical Foundation
- Study start
- 9 Jul 2025 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 8 Dec 2025 (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.
The goal of this clinical trial is to learn if osteopathic manipulative medicine (OMM) will allow for more uptake of isosulfan blue dye and radiotracers used in sentinal lymph node biopsy (SLNB) compared to massage alone. SLNB is used to characterize the stage and spread of cancer cells in breast cancer patients. The main questions it aims to answer is:
- Does OMM + massage allow for greater uptake of isosulfan blue dye and radiotracer in the lymph nodes compared to current standard of practice of breast massage after isosulfan blue dye and radiotracer injection.
Researchers will compare OMM + massage to current standard of practice of breast massage.
Randomization: Patients will be randomized prior to surgical intervention as to which arm of the study they will be assigned to: Massage (current standard) vs OMM + Massage
Massage: 9 minutes of circular massage over the nipple areolar complex to disperse isosulfan blue dye and radiotracer that were injected into the breast. Massage following injection is standard of care.
OMM+ Massage: 5 minutes of massage as above and then will perform osteopathic techniques including 1 minute of each of the following: opening the thoracic inlet, pectoral traction, and axillary pump. Thoracic pump will be done for 2 minutes. Isosulfan blue dye and radiotracer will then be injected followed by massage as done in the current standard of practice. The injection and massage are performed as per standard of care.
Detailed description
In order to appropriately and adequately treat breast cancer, sentinel lymph node mapping and biopsies are used to characterize stage and spread of cancer cells. Isosulfan blue dye and radiotracers are used to identify and target the sentinel lymph node and, therefore the specific group of lymphatic vessels that are draining the breast cancer. In order to identify the sentinel node, lymphatic vessels must be draining properly to allow for dye or radiotracer to have adequate uptake within the lymphatic system. Lymphatic vessels themselves or the fascia surrounding lymphatic vessels can have innate or pathological dysfunction that can be improved by osteopathic manipulation of these structures allowing for more accurate node identification with blue dye and radiotracer.
This study will look at the impact of osteopathic manipulation on fascia of the anterior chest wall as well as the lymphatic system draining the breast. We will compare the current standard of practice of breast massage after isosulfan blue dye and radiotracer injection to OMM + massage. Qualitative blue dye uptake in the sentinel lymph node as well as target values of radiotracer will be analyzed.
Two main points of data will be collected in order to determine how well the axilla mapped for that operation. These data points are the amount of isosulfan blue dye uptake in the lymph nodes and the target values on the neoprobe that tell how much radio tracer made it to those lymph nodes. The more blue in color a lymph node is and the higher the target value on the neoprobe determines if a node is the sentinel node in a typical breast cancer operation. We will use those same end points to assess if we have better uptake of blue dye or radio tracer in the axilla with or without the addition of OMM. In order to quantify the amount of blue dye uptake in a node, each node removed during the procedure will be categorized under blue or not blue. For those nodes that are blue, they will be analyzed as falling under 100%, 75%, 50%, or 25% blue. Meaning if half of the node is blue and half is a normal tissue color, this node would count under the 50% blue category. All blue nodes are typically removed during a sentinel lymph node operation. The second endpoint is the target value. The neoprobe detects and quantifies the amount of the radiotracer that was previously injected. If a node uptakes the radiotracer, it will be detected with the neoprobe. In a typical sentinel node operation, the nodes with the most tracer signal are removed and the target value (10 second count of the amount of radiotracer) is obtained for that node. Any other node in the axilla that is 10% of that highest target value will also be removed as it has the chance of being the sentinel node. For example if the hottest node in the axilla has a target value of 15000 then any node that is detected to have a value of 1500 or higher via the neoprobe will be removed. All radioactive nodes that fall into this 10% rule will be removed as per the usual surgery protocol and a target value obtained for each node. These values will be recorded as a way to determine how effective the radiotracer uptake was in the axilla.
Hypothesis: OMM + massage will have increased radiotracer target values and more isosulfan blue dye uptake in the sentinel lymph node compared to massage alone.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized in a 1:1 ratio to receive standard of care or intervention.
| Arm | Type | Receives |
|---|---|---|
| Massage | No intervention | –Patients will receive the standard of care practice for SLNB of 9 minutes of circular massage over the nipple areolar complex to disperse isosulfan blue dye and radiotracer that were injected into the breast. |
| OMM + Massage | Experimental | Procedure: OMM prior to SLNB5 min of massage plus perform osteopathic techniques including 1 minute of each of the following: opening the thoracic inlet, pectoral traction, and axillary pump. Thoracic pump will be done for 2 minutes. Isosulfan blue dye and radiotracer will then be injected followed by massage as done in the current standard of practice. The injection and massage are performed as per standard of care. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- First time breast cancer patients (female only) undergoing breast conserving surgery (lumpectomy or partial mastectomy) and sentinel lymph node biopsy.
Key exclusion criteria (7 listed)
- Previous breast cancer
- previous axillary surgery
- previous chest wall or axillary radiation
- previous breast surgery
- known axillary 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 |
|---|---|---|
| OMM prior to SLNBPerform osteopathic techniques including 1 minute of each of the following: opening the thoracic inlet, pectoral traction, and axillary pump. Thoracic pump will be done for 2 minutes. Isosulfan blue dye and radiotracer will then be injected followed by massage as done in the current standard of practice. The injection and massage are performed as per standard of care. | Procedure or surgery | OMM + Massage |
Primary outcome
Percentage of isosulfan blue dye uptake in the lymph nodes
Time frame: Through study completion, 4 months
In order to quantify the amount of blue dye uptake in a node, each node removed during the procedure will be categorized under blue or not blue. The percentage of blue dye uptake is determined visually by the operating surgeon. All surgeons were trained on how to identify these percentages. A node is labeled as 25% blue if it had a blue channel and/or minimal blue coloration of the node, 50% blue if it is a moderately/partially blue node, 75% blue if it was a mostly blue node, and 100% blue if it was a completely blue node.
1 secondary outcome
Target value of neoprobe that tell how much radiotracer makes it to the lymph nodes
Time frame: Through study completion, 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- 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.
Ivy Stejskal, DO principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OMM prior to SLNB in people with Breast Cancer, run by University of Arizona 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 1 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: finished, as of the sponsor's last update on 8 Dec 2025. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of isosulfan blue dye uptake in the lymph nodes (time frame: Through study completion, 4 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 8 Dec 2025.