Brain CancerPhase 2NCT04899908
Stereotactic Brain-directed Radiation With or Without Aguix Gadolinium-Based Nanoparticles in Brain Metastases
A Phase 2 study testing Stereotactic Radiation and AGuIX gadolinium-based nanoparticles in people with Brain Cancer and Brain Metastases, run by Brigham and Women's Hospital at 2 sites in United States.
Trial summary
The purpose of this study is to determine whether AGuIX (Activation and Guidance of Irradiation by X-ray) gadolinium-based nanoparticles make radiation work more effectively in the treatment of patients with brain metastases that are more difficult to control with stereotactic radiation alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Cancer, Brain Metastases, Melanoma
- What is being tested?
- Stereotactic Radiation and AGuIX gadolinium-based nanoparticles
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 134 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Sep 2021to May 2029
- 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
- Participants must have a biopsy proven solid malignancy and at least one intracranial measurable lesion spanning ≥5mm in maximal unidimensional size and radiographically consistent with or pathologically proven to be a brain metastasis AND meet one of the following additional criteria regarding the primary site or nature of the intracranial disease:
- Melanoma with intracranial growth consistent with tumor progression despite immunotherapy
- Gastrointestinal primary
- HER2 positive breast cancer (subtype assessed using most representative tissue available in opinion of enrolling clinician and/or study PI)
- Cystic metastases
- Metastases ≥2cm in maximal unidimensional size
Show all 14Show fewer
- Locally recurrent metastases after prior stereotactic radiation
- Locally recurrent metastases after prior whole brain radiation *Patients with metastases from melanoma, GI primaries, or HER2+ breast cancer, as well as those with cystic metastases or metastases ≥2cm in maximal unidimensional size, who have local recurrences after prior brain-directed radiation can only be treated in the strata permitting prior radiation (last two strata above)
- Age ≥18 years at diagnosis of brain metastases
- Estimated glomerular filtration rate of ≥ 60 mL/min/1.73m2
- Karnofsky performance status of at least 70 (i.e. at minimum, "cares for self" but "unable to carry on normal activity or do active work")
- Estimated survival based on extracranial disease of at least 3 months in the opinion of the enrolling clinician and/or study PI
- Ability to understand and the willingness to sign a written informed consent document
- The effects of AGuIX on the developing human fetus are unknown. For this reason, women of child-bearing potential must agree to use adequate contraception prior to study entry and for the duration of the therapeutic component of study participation
Who cannot join
- Participants who cannot undergo a brain MRI
- Participants who cannot receive gadolinium
- Participants with widespread, definitive leptomeningeal disease
- Patients requiring radiation to either >10 targets (if naïve to whole brain radiation) or >20 targets (if whole brain radiation has been given previously) per the discretion of the treating clinician and/or study PI
- Pregnant women are excluded from this study because of the potential deleterious effects of gadolinium on the developing fetus. Because there is an unknown but potential risk for adverse events in nursing infants, women who are breastfeeding are not eligible for this study
- In cohorts who have received prior brain-directed radiation, patients are not eligible for this study if they have active (at the time of protocol screening) brain metastases that require radiation that are in or within 1.0cm of the brainstem, eyes, optic nerves, or optic chiasm if the juxtaposed organ at risk (i.e. brainstem, eyes, optic nerves, or optic chiasm) has previously received either >6.0 Gy in a single fraction or, if prior radiation was fractionated, a cumulative dose in 2.0 Gy equivalents, using an alpha/beta ratio of 2, of >40.0 Gy. In addition, all patients who have had prior brain-directed radiation, regardless of technique/dose/fractionation, are not eligible for the study until written approval is provided by the study/site PI
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Ayal Aizer, 617-732-7560, aaaizer@partners.org
Ayal Aizer, MD, MHS
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Ayal Aizer, MD, MPH, 617-732-7560, aaaizer@partners.org
Ayal Aizer, MD, MPH
About this study
Official title: A Double-blind, Phase II Randomized Study of Brain-directed Stereotactic Radiation With or Without AGuIX Gadolinium-based Nanoparticles in the Management of Brain Metastases at Higher Risk of Local Recurrence With Radiation Alone
The purpose of this study is to determine whether AGuIX (Activation and Guidance of Irradiation by X-ray) gadolinium-based nanoparticles make radiation work more effectively in the treatment of patients with brain metastases that are more difficult to control with stereotactic radiation alone.
Read the detailed description
This research study is a double-blind, randomized phase II clinical trial of brain-directed stereotactic radiation with or without AGuIX (Activation and Guidance of Irradiation by X-ray) gadolinium-based nanoparticles in the management of brain metastases at higher-risk of local recurrence with radiation alone.
The study agent (AGuIX gadolinium-based nanoparticles) has two main parts. The first is gadolinium, also known as "contrast," which is typically injected into a vein during a MRI scan. The second part is a nanoparticle (linked to the gadolinium) that may make focused radiation work more effectively. The AGuIX gadolinium-based nanoparticles are deposited within the brain metastases via the bloodstream and then the brain metastases are radiated.
The U.S. Food and Drug Administration (FDA) has not approved AGuIX gadolinium-based nanoparticles as a treatment for any disease. AGuIX gadolinium-based nanoparticles have been tested in other studies for safety and efficacy in patients with brain metastases who are also receiving radiation.
This study seeks to determine whether AGuIX gadolinium-based nanoparticles improve outcomes relative to placebo.Participants will be "randomized" into one of the study groups:
- Group A: Radiation plus AGuIX gadolinium-based nanoparticles
- Group B: Radiation plus placebo
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
TherAguix, the manufacturer of the AGuIX gadolinium-based nanoparticles, is supporting this research study by providing the AGuIX gadolinium-based nanoparticles that will be evaluated in this study.
TherAguix is also covering the cost of the study.
It is expected that about 134 people will take part in this research study.
- Conditions
- Brain Cancer, Brain Metastases, Melanoma, Lung Cancer, Breast Cancer, HER2-positive Breast Cancer
- Being tested
- Stereotactic Radiation, AGuIX gadolinium-based nanoparticles, Placebo
- Keywords
- Brain Cancer, Brain Metastases, Melanoma, Lung Cancer, Breast Cancer, HER2-positive Breast Cancer, Colorectal Cancer, Gastrointestinal Cancer, SRS, SRT, Whole brain radiation, Stereotactic Radiation, AGuIX, Nanoparticle, Cystic, Brain Tumor
- Medical subject headings
- Brain Neoplasms, Melanoma, Lung Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic RadiationRadiation
Also called Stereotactic Radiotherapy
Focused radiation beams to treat tumors
AGuIX gadolinium-based nanoparticlesDrug
Intravenous injection
PlaceboOther
Also called Saline
Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic Radiation plus AGuIX gadolinium-based nanoparticles | Experimental | Randomly assigned participants will receive:
* AGuIX gadolinium-based nanoparticles 3-5 days before radiation is initiated
* AGuIX gadolinium-based up to 2x during radiation, depending on standard of care radiation treatment.
* If standard of care radiation treatment involves only one day of radiation, participant will receive AGuIX gadolinium-based nanoparticles on the day of radiation.
* If standard of care radiation treatment involves 5 or 6 days of radiation, participant will receive AGuIX gadolinium-based nanoparticles two-times (2x) in total, on the first and third day of radiation. Receives: Radiation: Stereotactic Radiation; Drug: AGuIX gadolinium-based nanoparticles |
| Stereotactic Radiation plus placebo | Experimental | Randomly assigned participants will receive:
* Placebo 3-5 days before radiation is initiated
* Placebo up to 2x during radiation, depending on standard of care radiation treatment.
* If standard of care radiation treatment involves only one day of radiation participant will receive Placebo on the day of radiation.
* If standard of care radiation treatment involves 5 or 6 days of radiation participant will receive Placebo two-times (2x) in total, on the first and third day of radiation. Receives: Radiation: Stereotactic Radiation; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Recurrence
Assessed with Response Assessment in Neuro-Oncology (RANO) - Brain Metastasis Guidelines Time to local failure on a per metastasis basis will be performed using the log-rank test.
Measured: From enrollment to 6 months
Secondary outcomes (19)
Overall Survival (OS)
Assessed with log-rank test
Measured: Time from enrollment to 12 months
Progression-Free Survival (PFS)
Assessed with log-rank test
Measured: Time from enrollment to 12 months
Time to Progression (TTP)
Assessed with log-rank test
Measured: Time from enrollment to 12 months
Death due to neurologic causes
Assessed with Gray's test
Measured: From enrollment to 12 months
Performance status
Karnofsky performance status, assessed longitudinally (longitudinal regression)
Measured: From enrollment to 12 months
Ability to complete activities of daily living
Questionnaire - EQ-5D, assessed longitudinally (longitudinal regression)
Measured: From enrollment to 12 months
Incidence and time to detection of new brain metastases
Assessed with log-rank test
Measured: From enrollment to 12 months
Incidence and time to detection of radiation necrosis
Assessed with log-rank test
Measured: From enrollment to 12 months
Incidence and time to detection of leptomeningeal disease
Assessed with log-rank test
Measured: From enrollment to 12 months
Incidence and time to detection of progressive intracranial disease
Assessed with log-rank test
Measured: From enrollment to 12 months
Incidence and time to detection of salvage craniotomy
Assessed with log-rank test
Measured: From enrollment to 12 months
Incidence and time to additional radiotherapeutic treatments
Assessed with log-rank test
Measured: From enrollment to 12 months
Incidence and time to the development of seizures
Assessed with log-rank test
Measured: From enrollment to 12 months
Steroid use
Assessed longitudinally (longitudinal regression)
Measured: From enrollment to 12 months
Local recurrence at one year in metastases treated radiotherapeutically
Assessed using RECIST (response evaluation criteria in solid tumors) criteria
Measured: From enrollment to 12 months
Neurocognitive function: verbal learning and memory
Hopkins Verbal Learning Test - Revised (HVLT-R)
Measured: From enrollment to 12 months
Neurocognitive function: visual attention and task switching
Trail Making Test Part A and B (TMT)
Measured: From enrollment to 12 months
Neurocognitive function: verbal fluency
Controlled Word Association Test (COWAT)
Measured: From enrollment to 12 months
Neurocognitive function: cognitive impairment
Mini Mental Status Examination (MMSE)
Measured: From enrollment to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start15 Sep 2021
- Primary completionApr 2028 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain CancerStudies of the same condition, open and under way.
- More trials run by Brigham and Women's 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, TherAguix
- Responsible party
- Principal investigator, Ayal A. Aizer, MD, Brigham and Women's Hospital
- Investigators
- Ayal Aizer, MD, MHS, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04899908
- Sponsor's protocol ID
- 20-240
- Status last verified
- Aug 2026
- First submitted
- 30 Apr 2021
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Publications
Bennett S, Verry C, Kaza E, Miao X, Dufort S, Boux F, Cremillieux Y, de Beaumont O, Le Duc G, Berbeco R, Sudhyadhom A. Quantifying gadolinium-based nanoparticle uptake distributions in brain metastases via magnetic resonance imaging. Sci Rep. 2024 May 25;14(1):11959. doi: 10.1038/s41598-024-62389-1.
PubMed 38796495
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Phase II Randomized Study of Brain-directed Stereotactic Radiation With or Without AGuIX Gadolinium-based Nanoparticles in the Management of Brain Metastases at Higher Risk of Local Recurrence With Radiation Alone
- ClinicalTrials.gov ID
- NCT04899908
- Acronym / sponsor ID
- 20-240
- Conditions
- Brain Cancer, Brain Metastases, Melanoma, Lung Cancer, Breast Cancer, HER2-positive Breast Cancer
- Keywords
- Brain Cancer, Brain Metastases, Melanoma, Lung Cancer, Breast Cancer, HER2-positive Breast Cancer, Colorectal Cancer, Gastrointestinal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, TherAguix
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 25 May 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.
The purpose of this study is to determine whether AGuIX (Activation and Guidance of Irradiation by X-ray) gadolinium-based nanoparticles make radiation work more effectively in the treatment of patients with brain metastases that are more difficult to control with stereotactic radiation alone.
Detailed description
This research study is a double-blind, randomized phase II clinical trial of brain-directed stereotactic radiation with or without AGuIX (Activation and Guidance of Irradiation by X-ray) gadolinium-based nanoparticles in the management of brain metastases at higher-risk of local recurrence with radiation alone.
The study agent (AGuIX gadolinium-based nanoparticles) has two main parts. The first is gadolinium, also known as "contrast," which is typically injected into a vein during a MRI scan. The second part is a nanoparticle (linked to the gadolinium) that may make focused radiation work more effectively. The AGuIX gadolinium-based nanoparticles are deposited within the brain metastases via the bloodstream and then the brain metastases are radiated.
The U.S. Food and Drug Administration (FDA) has not approved AGuIX gadolinium-based nanoparticles as a treatment for any disease. AGuIX gadolinium-based nanoparticles have been tested in other studies for safety and efficacy in patients with brain metastases who are also receiving radiation.
This study seeks to determine whether AGuIX gadolinium-based nanoparticles improve outcomes relative to placebo.Participants will be "randomized" into one of the study groups:
- Group A: Radiation plus AGuIX gadolinium-based nanoparticles
- Group B: Radiation plus placebo
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
TherAguix, the manufacturer of the AGuIX gadolinium-based nanoparticles, is supporting this research study by providing the AGuIX gadolinium-based nanoparticles that will be evaluated in this study.
TherAguix is also covering the cost of the study.
It is expected that about 134 people will take part in this research study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stereotactic Radiation plus AGuIX gadolinium-based nanoparticles | Experimental | Radiation: Stereotactic Radiation, Drug: AGuIX gadolinium-based nanoparticlesRandomly assigned participants will receive: * AGuIX gadolinium-based nanoparticles 3-5 days before radiation is initiated * AGuIX gadolinium-based up to 2x during radiation, depending on standard of care radiation treatment. * If standard of care radiation treatment involves only one day of radiation, participant will receive AGuIX gadolinium-based nanoparticles on the day of radiation. * If standard of care radiation treatment involves 5 or 6 days of radiation, participant will receive AGuIX gadolinium-based nanoparticles two-times (2x) in total, on the first and third day of radiation. |
| Stereotactic Radiation plus placebo | Experimental | Radiation: Stereotactic Radiation, Other: PlaceboRandomly assigned participants will receive: * Placebo 3-5 days before radiation is initiated * Placebo up to 2x during radiation, depending on standard of care radiation treatment. * If standard of care radiation treatment involves only one day of radiation participant will receive Placebo on the day of radiation. * If standard of care radiation treatment involves 5 or 6 days of radiation participant will receive Placebo two-times (2x) in total, on the first and third day of radiation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Participants must have a biopsy proven solid malignancy and at least one intracranial measurable lesion spanning ≥5mm in maximal unidimensional size and radiographically consistent with or pathologically proven to be a brain metastasis AND meet one of the following additional criteria regarding the primary site or nature of the intracranial disease:
- Age ≥18 years at diagnosis of brain metastases
- Estimated glomerular filtration rate of ≥ 60 mL/min/1.73m2
- Karnofsky performance status of at least 70 (i.e. at minimum, "cares for self" but "unable to carry on normal activity or do active work")
- Estimated survival based on extracranial disease of at least 3 months in the opinion of the enrolling clinician and/or study PI
Key exclusion criteria (6 listed)
- Participants who cannot undergo a brain MRI
- Participants who cannot receive gadolinium
- Participants with widespread, definitive leptomeningeal disease
- Patients requiring radiation to either >10 targets (if naïve to whole brain radiation) or >20 targets (if whole brain radiation has been given previously) per the discretion of the treating clinician and/or study PI
- Pregnant women are excluded from this study because of the potential deleterious effects of gadolinium on the developing fetus. Because there is an unknown but potential risk for adverse events in nursing infants, women who are breastfeeding are not eligible for this study
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 |
|---|---|---|
| Stereotactic RadiationAlso: Stereotactic RadiotherapyFocused radiation beams to treat tumors | Radiation | Stereotactic Radiation plus AGuIX gadolinium-based nanoparticles, Stereotactic Radiation plus placebo |
| AGuIX gadolinium-based nanoparticlesIntravenous injection | Drug | Stereotactic Radiation plus AGuIX gadolinium-based nanoparticles |
| PlaceboAlso: SalineIntravenous infusion | Other | Stereotactic Radiation plus placebo |
Primary outcome
Local Recurrence
Time frame: From enrollment to 6 months
Assessed with Response Assessment in Neuro-Oncology (RANO) - Brain Metastasis Guidelines Time to local failure on a per metastasis basis will be performed using the log-rank test.
19 secondary outcomes
Overall Survival (OS)
Time frame: Time from enrollment to 12 months
Progression-Free Survival (PFS)
Time frame: Time from enrollment to 12 months
Time to Progression (TTP)
Time frame: Time from enrollment to 12 months
Death due to neurologic causes
Time frame: From enrollment to 12 months
Performance status
Time frame: From enrollment to 12 months
Ability to complete activities of daily living
Time frame: From enrollment to 12 months
Incidence and time to detection of new brain metastases
Time frame: From enrollment to 12 months
Incidence and time to detection of radiation necrosis
Time frame: From enrollment to 12 months
Incidence and time to detection of leptomeningeal disease
Time frame: From enrollment to 12 months
Incidence and time to detection of progressive intracranial disease
Time frame: From enrollment to 12 months
Incidence and time to detection of salvage craniotomy
Time frame: From enrollment to 12 months
Incidence and time to additional radiotherapeutic treatments
Time frame: From enrollment to 12 months
Incidence and time to the development of seizures
Time frame: From enrollment to 12 months
Steroid use
Time frame: From enrollment to 12 months
Local recurrence at one year in metastases treated radiotherapeutically
Time frame: From enrollment to 12 months
Neurocognitive function: verbal learning and memory
Time frame: From enrollment to 12 months
Neurocognitive function: visual attention and task switching
Time frame: From enrollment to 12 months
Neurocognitive function: verbal fluency
Time frame: From enrollment to 12 months
Neurocognitive function: cognitive impairment
Time frame: From enrollment to 12 months
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 9 Sep 2026.
- Derived from this study: PubMed 38796495Bennett S, Verry C, Kaza E, Miao X, Dufort S, Boux F, Cremillieux Y, de Beaumont O, Le Duc G, Berbeco R, Sudhyadhom A. Quantifying gadolinium-based nanoparticle uptake distributions in brain metastases via magnetic resonance imaging. Sci Rep. 2024 May 25;14(1):11959. doi: 10.1038/s41598-024-62389-1.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Ayal Aizer, MD, MHS principal investigator
Brigham and Women's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stereotactic Radiation and AGuIX gadolinium-based nanoparticles in people with Brain Cancer and Brain Metastases, run by Brigham and Women's Hospital at 2 sites 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 14 inclusion and 6 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 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Ayal Aizer, MD, MHS ((617) 732-7560, aaaizer@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local Recurrence (time frame: From enrollment to 6 months). 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 NCT04899908, which also lists 1 linked publication.
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 9 Sep 2026.