Benign NeoplasmPhase 2NCT04752137
Intraoperative Tumor Margin Identification With ICG Dye Imaging
A Phase 2 study testing Indocyanine green and SPY-PHI in people with Benign Neoplasm and Malignant Neoplasm, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
In this research study we want to learn more about the use of indocyanine green (ICG) during bone or soft tissue mass resections. Indocyanine green (ICG) is a type of dye that is used in medical diagnostics. We want to determine if ICG-guided tumor resection is more effective in obtaining negative margins. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Benign Neoplasm, Malignant Neoplasm
- What is being tested?
- Indocyanine green and SPY-PHI
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2022to 1 Apr 2030
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients 18 years of age or older who present to Massachusetts General Hospital Department of Orthopaedic Surgery with a benign or malignant bone or soft tissue mass that is consented for surgery during the study period.
Who cannot join
- Pregnant or nursing patients
- Patients with previously known anaphylaxis to IV contrast or iodine (other allergies may be considered on a case-by-case basis)
- Patients in renal failure who are not cleared for ICG administration by their primary physician or oncologist
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Santiago A Lozano-Calderon, MD, PhD, 617-643-4947, slozanocalderon@mgh.harvard.edu
Shreya Halur, BS, 617-726-4932, shalur@mgh.harvard.edu
About this study
Official title: Evaluation of Intraoperative Tumor Margin Identification With Fluorescent Dye Imaging
In this research study we want to learn more about the use of indocyanine green (ICG) during bone or soft tissue mass resections. Indocyanine green (ICG) is a type of dye that is used in medical diagnostics. We want to determine if ICG-guided tumor resection is more effective in obtaining negative margins. Lastly, we want to assess traditional oncologic outcomes of local recurrence, time to metastatic disease, and overall and disease specific survival.
Read the detailed description
If you are present for a preoperative clinic visit the day before your surgery, ICG may be administered via injection. Otherwise, ICG will be administered in the preoperative unit via IV injection at the time of presentation approximately 4 hours before your surgery. You will be monitored during and after ICG dosing.
During surgery ICG fluorescence using a near-infrared imager will be performed at the time of and immediately following primary tumor resection. The imager will evaluate the primary tumor to ensure appropriate tumor fluorescence. Once the primary resection is complete and the surgeon believes that he/she has achieved negative or planned positive margins, fluorescence measurements of the tumor bed will be performed. If areas of positive signal remain, these areas will be resected if possible and sent to pathology for histologic evaluation. It will be recorded if the surgeon perceived negative margins but the device detected positive margins.
Tumor specimens and residual fluorescence positive samples will be evaluated using fresh frozen and permanent histology. Permanent samples will be evaluated for tumor and local fluorescence using confocal microscopy with an ICG cube. Positive fluorescence signal and its correspondence with neoplasm will be noted, a will tumor that does not fluoresce.
Tissue being removed is 1-2 mm from non-structurally important tissue that either has or does not have signal positivity for additional pathologic assessment. It should have no impact on patient outcome, does not represent intervention on sensitive areas (such as neurovascular structures), and can further be used as potential margin around the tumor.
- Conditions
- Benign Neoplasm, Malignant Neoplasm
- Being tested
- Indocyanine green, SPY-PHI
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine greenDrug
The SPY PHI and its dye Indocyanine Green dye (ICG) is a non-invasive device that is connected to a light source tower that is already available in the hospital in the operating room under Gynecology and Obstetrics Equipment. This is a special light source lamp that allows to test for vascularity in the soft tissues intraoperatively. Previous research in animal models proved the concept that the increased vascularity in tumors can be used to use this device to improve intraoperative assessment of tumor margins during resection. Our study will help to establish a correlation between activity with the dye and histological findings. This information has the potential to help sarcoma patients by avoiding staged surgeries, decreasing hospitalization times, and decreasing the likelihood of local recurrence by improving margin quality.
SPY-PHIDevice
The SPY PHI and its dye Indocyanine Green dye (ICG) is a non-invasive device that is connected to a light source tower that is already available in the hospital in the operating room under Gynecology and Obstetrics Equipment. This is a special light source lamp that allows to test for vascularity in the soft tissues intraoperatively. Previous research in animal models proved the concept that the increased vascularity in tumors can be used to use this device to improve intraoperative assessment of tumor margins during resection. Our study will help to establish a correlation between activity with the dye and histological findings. This information has the potential to help sarcoma patients by avoiding staged surgeries, decreasing hospitalization times, and decreasing the likelihood of local recurrence by improving margin quality.
| Study group | Role | What they receive |
|---|---|---|
| ICG Dye and use of SPY-PHI Imaging | Other | ICG will be administered in the pre-operative unit via IV injection at the time that they present to the pre-operative unit, which is approximately 4 hours before surgery. ICG Angiography (SPY PHI) will be performed to detect any residual signal Receives: Drug: Indocyanine green; Device: SPY-PHI |
What is being measured
The primary outcome is the main question the study is designed to answer.
image-guided prediction of local recurrence
The primary outcome of this work is image-guided prediction of local recurrence, defined as pathologically confirmed return of the resected tumor local to the prior excision bed within 2 years of the primary surgery.
Measured: 2 Years
Secondary outcomes (2)
Distant recurrence (metastatic disease)
If a participant develops metastatic disease after surgery with ICG and SPY-PHI.
Measured: 2 Years
physician-perceived vs. device measured negative margins
physician-perceived vs. device measured negative margins (compared using pathologic specimens), which will be measured against formal margin analysis performed by a pathologist during the routine standard of care.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start25 May 2022
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Benign NeoplasmStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Santiago Lozano-Calderon, Massachusetts General Hospital
- Investigators
- Santiago A Lozano-Calderon, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04752137
- Sponsor's protocol ID
- 2020P003481
- Status last verified
- Apr 2026
- First submitted
- 3 Feb 2021
- Last updated
- 24 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Wasif N. Comparative effectiveness research for sarcoma. Cancer Treat Res. 2015;164:51-65. doi: 10.1007/978-3-319-12553-4_4.
PubMed 25677018Fourman MS, Mahjoub A, Mandell JB, Yu S, Tebbets JC, Crasto JA, Alexander PE, Weiss KR. Quantitative Primary Tumor Indocyanine Green Measurements Predict Osteosarcoma Metastatic Lung Burden in a Mouse Model. Clin Orthop Relat Res. 2018 Mar;476(3):479-487. doi: 10.1007/s11999.0000000000000003.
PubMed 29408832Harati K, Lehnhardt M. The changing paradigm of resection margins in sarcoma resection. Innov Surg Sci. 2017 Dec 6;2(4):165-170. doi: 10.1515/iss-2017-0043. eCollection 2017 Dec.
PubMed 31579750Rath B, Hardes J, Tingart M, Braunschweig T, Eschweiler J, Migliorini F. [Resection margins in soft tissue sarcomas]. Orthopade. 2019 Sep;48(9):768-775. doi: 10.1007/s00132-019-03795-6. German.
PubMed 31463543Goertz O, Pieper A, Lohe LV, Stricker I, Dadras M, Behr B, Lehnhardt M, Harati K. The Impact of Surgical Margins and Adjuvant Radiotherapy in Patients with Undifferentiated Pleomorphic Sarcomas of the Extremities: A Single-Institutional Analysis of 192 Patients. Cancers (Basel). 2020 Feb 5;12(2):362. doi: 10.3390/cancers12020362.
PubMed 32033261Harati K, Goertz O, Pieper A, Daigeler A, Joneidi-Jafari H, Niggemann H, Stricker I, Lehnhardt M. Soft Tissue Sarcomas of the Extremities: Surgical Margins Can Be Close as Long as the Resected Tumor Has No Ink on It. Oncologist. 2017 Nov;22(11):1400-1410. doi: 10.1634/theoncologist.2016-0498. Epub 2017 Jul 24.
PubMed 28739867Fourman MS, Gersch RP, Levites HA, Phillips BT, Bui DT. Is There a Right Way to Interpret SPY? Normalization of Indocyanine Green Angiography Readings in a Burn Model. Plast Reconstr Surg. 2015 Jul;136(1):128e-130e. doi: 10.1097/PRS.0000000000001380. No abstract available.
PubMed 25803152Crasto JA, Fourman MS, Morales-Restrepo A, Mahjoub A, Mandell JB, Ramnath K, Tebbets JC, Watters RJ, Weiss KR. Disulfiram reduces metastatic osteosarcoma tumor burden in an immunocompetent Balb/c or-thotopic mouse model. Oncotarget. 2018 Jul 10;9(53):30163-30172. doi: 10.18632/oncotarget.25733. eCollection 2018 Jul 10.
PubMed 30046395Mahjoub A, Morales-Restrepo A, Fourman MS, Mandell JB, Feiqi L, Hankins ML, Watters RJ, Weiss KR. Tumor Resection Guided by Intraoperative Indocyanine Green Dye Fluorescence Angiography Results in Negative Surgical Margins and Decreased Local Recurrence in an Orthotopic Mouse Model of Osteosarcoma. Ann Surg Oncol. 2019 Mar;26(3):894-898. doi: 10.1245/s10434-018-07114-9. Epub 2018 Dec 27.
PubMed 30588559Gilg MM, Sunitsch S, Leitner L, Bergovec M, Szkandera J, Leithner A, Liegl-Atzwanger B. Tumor-associated mortality and prognostic factors in myxofibrosarcoma - A retrospective review of 109 patients. Orthop Traumatol Surg Res. 2020 Oct;106(6):1059-1065. doi: 10.1016/j.otsr.2020.04.017. Epub 2020 Aug 7.
PubMed 32778437Newton AD, Predina JD, Corbett CJ, Frenzel-Sulyok LG, Xia L, Petersson EJ, Tsourkas A, Nie S, Delikatny EJ, Singhal S. Optimization of Second Window Indocyanine Green for Intraoperative Near-Infrared Imaging of Thoracic Malignancy. J Am Coll Surg. 2019 Feb;228(2):188-197. doi: 10.1016/j.jamcollsurg.2018.11.003. Epub 2018 Nov 22.
PubMed 30471345Madajewski B, Judy BF, Mouchli A, Kapoor V, Holt D, Wang MD, Nie S, Singhal S. Intraoperative near-infrared imaging of surgical wounds after tumor resections can detect residual disease. Clin Cancer Res. 2012 Oct 15;18(20):5741-51. doi: 10.1158/1078-0432.CCR-12-1188. Epub 2012 Aug 29.
PubMed 22932668Holt D, Parthasarathy AB, Okusanya O, Keating J, Venegas O, Deshpande C, Karakousis G, Madajewski B, Durham A, Nie S, Yodh AG, Singhal S. Intraoperative near-infrared fluorescence imaging and spectroscopy identifies residual tumor cells in wounds. J Biomed Opt. 2015 Jul;20(7):76002. doi: 10.1117/1.JBO.20.7.076002.
PubMed 26160347
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Intraoperative Tumor Margin Identification With Fluorescent Dye Imaging
- ClinicalTrials.gov ID
- NCT04752137
- Acronym / sponsor ID
- 2020P003481
- Conditions
- Benign Neoplasm, Malignant Neoplasm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 25 May 2022 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2030 (estimated)
- First posted
- 12 Feb 2021 (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.
In this research study we want to learn more about the use of indocyanine green (ICG) during bone or soft tissue mass resections. Indocyanine green (ICG) is a type of dye that is used in medical diagnostics. We want to determine if ICG-guided tumor resection is more effective in obtaining negative margins. Lastly, we want to assess traditional oncologic outcomes of local recurrence, time to metastatic disease, and overall and disease specific survival.
Detailed description
If you are present for a preoperative clinic visit the day before your surgery, ICG may be administered via injection. Otherwise, ICG will be administered in the preoperative unit via IV injection at the time of presentation approximately 4 hours before your surgery. You will be monitored during and after ICG dosing.
During surgery ICG fluorescence using a near-infrared imager will be performed at the time of and immediately following primary tumor resection. The imager will evaluate the primary tumor to ensure appropriate tumor fluorescence. Once the primary resection is complete and the surgeon believes that he/she has achieved negative or planned positive margins, fluorescence measurements of the tumor bed will be performed. If areas of positive signal remain, these areas will be resected if possible and sent to pathology for histologic evaluation. It will be recorded if the surgeon perceived negative margins but the device detected positive margins.
Tumor specimens and residual fluorescence positive samples will be evaluated using fresh frozen and permanent histology. Permanent samples will be evaluated for tumor and local fluorescence using confocal microscopy with an ICG cube. Positive fluorescence signal and its correspondence with neoplasm will be noted, a will tumor that does not fluoresce.
Tissue being removed is 1-2 mm from non-structurally important tissue that either has or does not have signal positivity for additional pathologic assessment. It should have no impact on patient outcome, does not represent intervention on sensitive areas (such as neurovascular structures), and can further be used as potential margin around the tumor.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICG Dye and use of SPY-PHI Imaging | Other | Drug: Indocyanine green, Device: SPY-PHIICG will be administered in the pre-operative unit via IV injection at the time that they present to the pre-operative unit, which is approximately 4 hours before surgery. ICG Angiography (SPY PHI) will be performed to detect any residual signal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients 18 years of age or older who present to Massachusetts General Hospital Department of Orthopaedic Surgery with a benign or malignant bone or soft tissue mass that is consented for surgery during the study period.
Key exclusion criteria (3 listed)
- Pregnant or nursing patients
- Patients with previously known anaphylaxis to IV contrast or iodine (other allergies may be considered on a case-by-case basis)
- Patients in renal failure who are not cleared for ICG administration by their primary physician or oncologist
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 |
|---|---|---|
| Indocyanine greenThe SPY PHI and its dye Indocyanine Green dye (ICG) is a non-invasive device that is connected to a light source tower that is already available in the hospital in the operating room under Gynecology and Obstetrics Equipment. This is a special light source lamp that allows to test for vascularity in the soft tissues intraoperatively. Previous research in animal models proved the concept that the increased vascularity in tumors can be used to use this device to improve intraoperative assessment of tumor margins during resection. Our study will help to establish a correlation between activity with the dye and histological findings. This information has the potential to help sarcoma patients by avoiding staged surgeries, decreasing hospitalization times, and decreasing the likelihood of local recurrence by improving margin quality. | Drug | ICG Dye and use of SPY-PHI Imaging |
| SPY-PHIThe SPY PHI and its dye Indocyanine Green dye (ICG) is a non-invasive device that is connected to a light source tower that is already available in the hospital in the operating room under Gynecology and Obstetrics Equipment. This is a special light source lamp that allows to test for vascularity in the soft tissues intraoperatively. Previous research in animal models proved the concept that the increased vascularity in tumors can be used to use this device to improve intraoperative assessment of tumor margins during resection. Our study will help to establish a correlation between activity with the dye and histological findings. This information has the potential to help sarcoma patients by avoiding staged surgeries, decreasing hospitalization times, and decreasing the likelihood of local recurrence by improving margin quality. | Device | ICG Dye and use of SPY-PHI Imaging |
Primary outcome
image-guided prediction of local recurrence
Time frame: 2 Years
The primary outcome of this work is image-guided prediction of local recurrence, defined as pathologically confirmed return of the resected tumor local to the prior excision bed within 2 years of the primary surgery.
2 secondary outcomes
Distant recurrence (metastatic disease)
Time frame: 2 Years
physician-perceived vs. device measured negative margins
Time frame: 14 days
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 24 Apr 2026.
- Background: PubMed 25677018Wasif N. Comparative effectiveness research for sarcoma. Cancer Treat Res. 2015;164:51-65. doi: 10.1007/978-3-319-12553-4_4.
- Background: PubMed 29408832Fourman MS, Mahjoub A, Mandell JB, Yu S, Tebbets JC, Crasto JA, Alexander PE, Weiss KR. Quantitative Primary Tumor Indocyanine Green Measurements Predict Osteosarcoma Metastatic Lung Burden in a Mouse Model. Clin Orthop Relat Res. 2018 Mar;476(3):479-487. doi: 10.1007/s11999.0000000000000003.
- Background: PubMed 31579750Harati K, Lehnhardt M. The changing paradigm of resection margins in sarcoma resection. Innov Surg Sci. 2017 Dec 6;2(4):165-170. doi: 10.1515/iss-2017-0043. eCollection 2017 Dec.
- Background: PubMed 31463543Rath B, Hardes J, Tingart M, Braunschweig T, Eschweiler J, Migliorini F. [Resection margins in soft tissue sarcomas]. Orthopade. 2019 Sep;48(9):768-775. doi: 10.1007/s00132-019-03795-6. German.
- Background: PubMed 32033261Goertz O, Pieper A, Lohe LV, Stricker I, Dadras M, Behr B, Lehnhardt M, Harati K. The Impact of Surgical Margins and Adjuvant Radiotherapy in Patients with Undifferentiated Pleomorphic Sarcomas of the Extremities: A Single-Institutional Analysis of 192 Patients. Cancers (Basel). 2020 Feb 5;12(2):362. doi: 10.3390/cancers12020362.
- Background: PubMed 28739867Harati K, Goertz O, Pieper A, Daigeler A, Joneidi-Jafari H, Niggemann H, Stricker I, Lehnhardt M. Soft Tissue Sarcomas of the Extremities: Surgical Margins Can Be Close as Long as the Resected Tumor Has No Ink on It. Oncologist. 2017 Nov;22(11):1400-1410. doi: 10.1634/theoncologist.2016-0498. Epub 2017 Jul 24.
- Background: PubMed 25803152Fourman MS, Gersch RP, Levites HA, Phillips BT, Bui DT. Is There a Right Way to Interpret SPY? Normalization of Indocyanine Green Angiography Readings in a Burn Model. Plast Reconstr Surg. 2015 Jul;136(1):128e-130e. doi: 10.1097/PRS.0000000000001380. No abstract available.
- Background: PubMed 30046395Crasto JA, Fourman MS, Morales-Restrepo A, Mahjoub A, Mandell JB, Ramnath K, Tebbets JC, Watters RJ, Weiss KR. Disulfiram reduces metastatic osteosarcoma tumor burden in an immunocompetent Balb/c or-thotopic mouse model. Oncotarget. 2018 Jul 10;9(53):30163-30172. doi: 10.18632/oncotarget.25733. eCollection 2018 Jul 10.
- Background: PubMed 30588559Mahjoub A, Morales-Restrepo A, Fourman MS, Mandell JB, Feiqi L, Hankins ML, Watters RJ, Weiss KR. Tumor Resection Guided by Intraoperative Indocyanine Green Dye Fluorescence Angiography Results in Negative Surgical Margins and Decreased Local Recurrence in an Orthotopic Mouse Model of Osteosarcoma. Ann Surg Oncol. 2019 Mar;26(3):894-898. doi: 10.1245/s10434-018-07114-9. Epub 2018 Dec 27.
- Background: PubMed 32778437Gilg MM, Sunitsch S, Leitner L, Bergovec M, Szkandera J, Leithner A, Liegl-Atzwanger B. Tumor-associated mortality and prognostic factors in myxofibrosarcoma - A retrospective review of 109 patients. Orthop Traumatol Surg Res. 2020 Oct;106(6):1059-1065. doi: 10.1016/j.otsr.2020.04.017. Epub 2020 Aug 7.
- Background: PubMed 30471345Newton AD, Predina JD, Corbett CJ, Frenzel-Sulyok LG, Xia L, Petersson EJ, Tsourkas A, Nie S, Delikatny EJ, Singhal S. Optimization of Second Window Indocyanine Green for Intraoperative Near-Infrared Imaging of Thoracic Malignancy. J Am Coll Surg. 2019 Feb;228(2):188-197. doi: 10.1016/j.jamcollsurg.2018.11.003. Epub 2018 Nov 22.
- Background: PubMed 22932668Madajewski B, Judy BF, Mouchli A, Kapoor V, Holt D, Wang MD, Nie S, Singhal S. Intraoperative near-infrared imaging of surgical wounds after tumor resections can detect residual disease. Clin Cancer Res. 2012 Oct 15;18(20):5741-51. doi: 10.1158/1078-0432.CCR-12-1188. Epub 2012 Aug 29.
- 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.
Santiago A Lozano-Calderon, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Indocyanine green and SPY-PHI in people with Benign Neoplasm and Malignant Neoplasm, run by Massachusetts General Hospital 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 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: looking for participants now, as of the sponsor's last update on 24 Apr 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Santiago A Lozano-Calderon, MD, PhD ((617) 643-4947, SLOZANOCALDERON@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
image-guided prediction of local recurrence (time frame: 2 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04752137, which also lists 13 linked publications.
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 24 Apr 2026.