Pancreatic Ductal AdenocarcinomaNCT06600906
Hyperpolarized 13C MRI to Predict Response in Pancreatic Cancer
An observational study of Pancreatic Ductal Adenocarcinoma and Metastatic Pancreatic Ductal Adenocarcinoma, run by University of California, San Francisco at 1 site in United States.
Trial summary
This study evaluates an investigational scan called hyperpolarized carbon-13 pyruvate magnetic resonance imaging (MRI) in assessing treatment response in patients with pancreatic ductal carcinoma (PDA) that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma, Metastatic Pancreatic Ductal Adenocarcinoma, Locally Advanced Pancreatic Ductal Adenocarcinoma
- What is being tested?
- Hyperpolarized 13C-Pyruvate, Computed tomography (CT) and Magnetic Resonance Imaging (MRI)
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to 1 Sep 2032
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults receiving standard of care at University of California, San Francisco with biopsy-proven locally advanced or metastatic pancreatic ductal adenocarcinoma.
Who may be able to join
- Participants must be 18 years or older.
- Histological or cytological confirmation of pancreatic ductal adenocarcinoma (PDA).
- Locally advanced or metastatic disease.
- At least one target lesion in the abdomen measuring ≥ 1centimeter (cm), according to RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2 (Karnofsky ≥ 50%)
- Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or endpoints of this study are eligible.
- Ability to understand and willingness to sign a written informed consent document.
Who cannot join
- Participants unwilling or unable to undergo magnetic resonance (MR) imaging, including patients with contra-indications to MRI, such as cardiac pacemakers or non-compatible intracranial vascular clips.
- Poorly controlled hypertension, defined as either systolic > 170 or diastolic > 110. The addition of anti-hypertensives to control blood pressure is allowed for eligibility determination.
- Congestive Heart Failure ≥ Class III.
- Participants who are pregnant.
- Individuals of childbearing potential must agree to undergo a urine pregnancy test prior to participating in the study scans. Pregnant individuals are excluded because there is an unknown but potential risk for adverse effects in the unborn child secondary to administration of HP 13C pyruvate to the study participant. A female is considered to not be of childbearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice), if they meet either of the following two criteria: (1) has reached a postmenopausal state (>= 12 continuous months of amenorrhea with no identified cause other than menopause); or (2) has undergone surgical sterilization (i.e., hysterectomy and/or bilateral oophorectomy for removal of uterus and/or ovaries).
- Participants who are breastfeeding/chestfeeding. Breastfeeding/chestfeeding individuals are excluded because there is an unknown but potential risk for adverse effects in the unborn/nursing child secondary to administration of HP 13C pyruvate to the study participant. Breastfeeding/chestfeeding should be discontinued before administration of HP 13C pyruvate.
- Known hypersensitivity to HP 13C pyruvate or any of its excipients.
- Participants with any condition or social circumstance that, in the opinion of the investigator, would impair the participant's ability to comply with study procedures
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
University of California, San Francisco
San Francisco, California, 94143
Louise Magat, (415) 502-1822, Louise.Magat@ucsf.edu
877-827-3222, cancertrials@ucsf.edu
About this study
Official title: Translating Hyperpolarized 13C MRI as a Novel Tool to Predict Treatment Response in Pancreatic Cancer
This study evaluates an investigational scan called hyperpolarized carbon-13 pyruvate magnetic resonance imaging (MRI) in assessing treatment response in patients with pancreatic ductal carcinoma (PDA) that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). MRI is a standard scan that helps doctors see tumors, organs, tissue, and bone. Standard contrast agents (e.g., gadolinium) are sometimes used to help make the scan images brighter, or easier to see. Hyperpolarized carbon-13 pyruvate is an experimental contrast agent that is different from standard MRI contrast in that it provides information on how a tumor processes nutrients. Hyperpolarized carbon-13 pyruvate MRI scans may work better than MRI with standard contrast agents in predicting how PDA tumors respond to treatment.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the percent changes in target tumor (primary tumor and/or abdominal metastases) hyperpolarized carbon C 13 pyruvate (HP 13C pyruvate) metabolism measures between the pre-treatment scan and the scan obtained 4 weeks (± 2 weeks) following treatment initiation. (Cohorts A and B).
II. To determine whether the changes in these metabolism measures are associated with best objective response (as defined by Response Evaluation Criteria in Solid Tumors [RECIST] version [v]1.1) on subsequent clinical computed tomography (CT) scans. (Cohorts A and B).
SECONDARY OBJECTIVES:
- In patients who proceed to surgery following neoadjuvant therapy (NAT), to determine whether the HP 13C pyruvate metabolism in the primary tumor on the pre-operative MRI or the change in HP 13C pyruvate metabolism are associated with pathological response. (Cohort B).
II. To examine models from the primary objective where multiple imputation is used for where only pre-treatment imaging is available. (Cohorts A and B).
EXPLORATORY OBJECTIVES:
- To determine whether the changes in target tumor (primary tumor and/or abdominal metastases) HP 13C pyruvate metabolism measures at 8 weeks (± 2 weeks) following treatment initiation are associated with best objective response as defined by RECIST v1.1 on subsequent clinical CT scans and clinical variables. (Cohort A).
II. To determine the repeatability of HP 13C pyruvate metabolism measures in the target tumor (primary tumor and/or abdominal metastasis) in patients with same-day repeated dose. (Cohorts A and B).
III. To compare the changes in HP 13C pyruvate metabolism measures to changes in tumor size and tumor apparent diffusion coefficients on the concurrently acquired 1H MRI. (Cohorts A and B).
IV. To determine whether the changes in target tumor (primary tumor and/or abdominal metastases) HP 13C pyruvate metabolism measures at 4 weeks (± 2 weeks) following treatment initiation (Cohorts A and B), 8 weeks (± 2 weeks) following treatment initiation (Cohort A), and after completion of NAT (Cohort B) are associated with progression-free survival (PFS) and overall survival (OS). (Cohorts A and B).
OUTLINE: Patients are assigned to 1 of 2 cohorts.
COHORT A: Patients with advanced/non-resectable pancreatic ductal carcinoma (PDA) receive HP 13C pyruvate intravenously (IV) and undergo MRI scans prior to receiving standard of care (SOC) treatment and again at 4 weeks after starting SOC treatment. Patients may optionally undergo an additional HP 13C pyruvate MRI scan at 8 weeks after starting SOC treatment. Patients who have excellent response and deemed candidates for surgical resection may be switched to Cohort B.
COHORT B: Patients with localized PDA who are deemed candidates for NAT receive HP 13C pyruvate IV and undergo MRI scans prior to starting NAT and again at 4 weeks after starting NAT. Patients may optionally undergo an additional HP 13C pyruvate MRI scan at 8 weeks after starting NAT. Patients who develop rapidly progressive disease and are deemed non-resectable may be switched to Cohort A.
Patients in both cohorts also undergo CT and additional MRI scans throughout the study.
- Conditions
- Pancreatic Ductal Adenocarcinoma, Metastatic Pancreatic Ductal Adenocarcinoma, Locally Advanced Pancreatic Ductal Adenocarcinoma
- Being tested
- Hyperpolarized 13C-Pyruvate, Computed tomography (CT), Magnetic Resonance Imaging (MRI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperpolarized 13C-PyruvateDrug
Also called HP 13C
Given intravenously (IV)
Computed tomography (CT)Procedure or surgery
Also called CT
Undergo CT imaging
Magnetic Resonance Imaging (MRI)Procedure or surgery
Also called MRI
Undergo MRI imaging
| Study group | Role | What they receive |
|---|---|---|
| Cohort A (HP 13C pyruvate, MRI) | Participants with advanced/non-resectable pancreatic ductal adenocarcinoma (PDA) receive HP 13C pyruvate intravenously (IV) and undergo MRI scans prior to receiving standard-of-care (SOC) treatment and again at 4 weeks after starting SOC treatment. Participants may optionally undergo an additional HP 13C pyruvate MRI scan at 8 weeks after starting SOC treatment. Participants who have excellent response and deemed candidates for surgical resection may be switched to Cohort B. Participants also undergo CT and additional MRI scans throughout the study. Receives: Drug: Hyperpolarized 13C-Pyruvate; Procedure: Computed tomography (CT); Procedure: Magnetic Resonance Imaging (MRI) | |
| Cohort B (HP 13C pyruvate, MRI) | Participants with localized PDA who are deemed candidates for neoadjuvant therapy (NAT) receive HP 13C pyruvate IV and undergo MRI scans prior to starting NAT and again at 4 weeks after starting NAT. Participants may optionally undergo an additional HP 13C pyruvate MRI scan at 8 weeks after starting NAT. Participants who develop rapidly progressive disease and are deemed non-resectable may be switched to Cohort A. Participants also undergo CT and additional MRI scans throughout the study. Receives: Drug: Hyperpolarized 13C-Pyruvate; Procedure: Computed tomography (CT); Procedure: Magnetic Resonance Imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with best objective response (Cohorts A and B)
The best objective response based on clinical imaging according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.11 will be reported
Measured: Up to 24 months
Mean percent change in target tumor peak HP 13C lactate/pyruvate ratio over time
The mean percent change in peak HP 13C lactate/pyruvate ratio with 95% confidence intervals (CI) will be reported for scans completed at baseline and after 4 weeks (+/- 2 weeks) of non-interventional, standard of care treatment.
Measured: Up to 6 weeks
Mean change in target tumor HP 13C lactate/pyruvate area under the curve (AUC) ratio over time
The mean change in HP 13C lactate/pyruvate area under the curve (AUC) ratio will be reported for scans completed at baseline and scans after 4 weeks (+/- 2 weeks) of non-interventional, standard of care treatment.
Measured: Up to 6 weeks
Mean percent change in target tumor HP 13C pyruvate to lactate conversion rate (kPL).
The mean percent change in pyruvate to lactate conversion rate (kPL) will be reported for scans completed at baseline and scans after 4 weeks (+/- 2 weeks) of non-interventional, standard of care treatment.
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2024
- Primary completion1 Aug 2030 (estimated)
- Study completion1 Sep 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Zhen Wang, MD, University of California, San Francisco
- Investigators
- Zhen Wang, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06600906
- Sponsor's protocol ID
- 24928
- Other IDs
- NCI-2024-07399, R01CA280071
- Status last verified
- Nov 2025
- First submitted
- 14 Sep 2024
- Last updated
- 12 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translating Hyperpolarized 13C MRI as a Novel Tool to Predict Treatment Response in Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06600906
- Acronym / sponsor ID
- 24928
- Conditions
- Pancreatic Ductal Adenocarcinoma, Metastatic Pancreatic Ductal Adenocarcinoma, Locally Advanced Pancreatic Ductal Adenocarcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Aug 2030 (estimated)
- Study completion
- 1 Sep 2032 (estimated)
- First posted
- 19 Sep 2024 (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.
This study evaluates an investigational scan called hyperpolarized carbon-13 pyruvate magnetic resonance imaging (MRI) in assessing treatment response in patients with pancreatic ductal carcinoma (PDA) that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). MRI is a standard scan that helps doctors see tumors, organs, tissue, and bone. Standard contrast agents (e.g., gadolinium) are sometimes used to help make the scan images brighter, or easier to see. Hyperpolarized carbon-13 pyruvate is an experimental contrast agent that is different from standard MRI contrast in that it provides information on how a tumor processes nutrients. Hyperpolarized carbon-13 pyruvate MRI scans may work better than MRI with standard contrast agents in predicting how PDA tumors respond to treatment.
Detailed description
PRIMARY OBJECTIVES:
- To determine the percent changes in target tumor (primary tumor and/or abdominal metastases) hyperpolarized carbon C 13 pyruvate (HP 13C pyruvate) metabolism measures between the pre-treatment scan and the scan obtained 4 weeks (± 2 weeks) following treatment initiation. (Cohorts A and B).
II. To determine whether the changes in these metabolism measures are associated with best objective response (as defined by Response Evaluation Criteria in Solid Tumors [RECIST] version [v]1.1) on subsequent clinical computed tomography (CT) scans. (Cohorts A and B).
SECONDARY OBJECTIVES:
- In patients who proceed to surgery following neoadjuvant therapy (NAT), to determine whether the HP 13C pyruvate metabolism in the primary tumor on the pre-operative MRI or the change in HP 13C pyruvate metabolism are associated with pathological response. (Cohort B).
II. To examine models from the primary objective where multiple imputation is used for where only pre-treatment imaging is available. (Cohorts A and B).
EXPLORATORY OBJECTIVES:
- To determine whether the changes in target tumor (primary tumor and/or abdominal metastases) HP 13C pyruvate metabolism measures at 8 weeks (± 2 weeks) following treatment initiation are associated with best objective response as defined by RECIST v1.1 on subsequent clinical CT scans and clinical variables. (Cohort A).
II. To determine the repeatability of HP 13C pyruvate metabolism measures in the target tumor (primary tumor and/or abdominal metastasis) in patients with same-day repeated dose. (Cohorts A and B).
III. To compare the changes in HP 13C pyruvate metabolism measures to changes in tumor size and tumor apparent diffusion coefficients on the concurrently acquired 1H MRI. (Cohorts A and B).
IV. To determine whether the changes in target tumor (primary tumor and/or abdominal metastases) HP 13C pyruvate metabolism measures at 4 weeks (± 2 weeks) following treatment initiation (Cohorts A and B), 8 weeks (± 2 weeks) following treatment initiation (Cohort A), and after completion of NAT (Cohort B) are associated with progression-free survival (PFS) and overall survival (OS). (Cohorts A and B).
OUTLINE: Patients are assigned to 1 of 2 cohorts.
COHORT A: Patients with advanced/non-resectable pancreatic ductal carcinoma (PDA) receive HP 13C pyruvate intravenously (IV) and undergo MRI scans prior to receiving standard of care (SOC) treatment and again at 4 weeks after starting SOC treatment. Patients may optionally undergo an additional HP 13C pyruvate MRI scan at 8 weeks after starting SOC treatment. Patients who have excellent response and deemed candidates for surgical resection may be switched to Cohort B.
COHORT B: Patients with localized PDA who are deemed candidates for NAT receive HP 13C pyruvate IV and undergo MRI scans prior to starting NAT and again at 4 weeks after starting NAT. Patients may optionally undergo an additional HP 13C pyruvate MRI scan at 8 weeks after starting NAT. Patients who develop rapidly progressive disease and are deemed non-resectable may be switched to Cohort A.
Patients in both cohorts also undergo CT and additional MRI scans throughout the study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A (HP 13C pyruvate, MRI) | – | Drug: Hyperpolarized 13C-Pyruvate, Procedure: Computed tomography (CT), Procedure: Magnetic Resonance Imaging (MRI)Participants with advanced/non-resectable pancreatic ductal adenocarcinoma (PDA) receive HP 13C pyruvate intravenously (IV) and undergo MRI scans prior to receiving standard-of-care (SOC) treatment and again at 4 weeks after starting SOC treatment. Participants may optionally undergo an additional HP 13C pyruvate MRI scan at 8 weeks after starting SOC treatment. Participants who have excellent response and deemed candidates for surgical resection may be switched to Cohort B. Participants also undergo CT and additional MRI scans throughout the study. |
| Cohort B (HP 13C pyruvate, MRI) | – | Drug: Hyperpolarized 13C-Pyruvate, Procedure: Computed tomography (CT), Procedure: Magnetic Resonance Imaging (MRI)Participants with localized PDA who are deemed candidates for neoadjuvant therapy (NAT) receive HP 13C pyruvate IV and undergo MRI scans prior to starting NAT and again at 4 weeks after starting NAT. Participants may optionally undergo an additional HP 13C pyruvate MRI scan at 8 weeks after starting NAT. Participants who develop rapidly progressive disease and are deemed non-resectable may be switched to Cohort A. Participants also undergo CT and additional MRI scans throughout the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults receiving standard of care at University of California, San Francisco with biopsy-proven locally advanced or metastatic pancreatic ductal adenocarcinoma.
Key inclusion criteria (7 listed)
- Participants must be 18 years or older.
- Histological or cytological confirmation of pancreatic ductal adenocarcinoma (PDA).
- Locally advanced or metastatic disease.
- At least one target lesion in the abdomen measuring ≥ 1centimeter (cm), according to RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2 (Karnofsky ≥ 50%)
Key exclusion criteria (8 listed)
- Participants unwilling or unable to undergo magnetic resonance (MR) imaging, including patients with contra-indications to MRI, such as cardiac pacemakers or non-compatible intracranial vascular clips.
- Poorly controlled hypertension, defined as either systolic > 170 or diastolic > 110. The addition of anti-hypertensives to control blood pressure is allowed for eligibility determination.
- Congestive Heart Failure ≥ Class III.
- Participants who are pregnant.
- Individuals of childbearing potential must agree to undergo a urine pregnancy test prior to participating in the study scans. Pregnant individuals are excluded because there is an unknown but potential risk for adverse effects in the unborn child secondary to administration of HP 13C pyruvate to the study participant. A female is considered to not be of childbearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice), if they meet either of the following two criteria: (1) has reached a postmenopausal state (>= 12 continuous months of amenorrhea with no identified cause other than menopause); or (2) has undergone surgical sterilization (i.e., hysterectomy and/or bilateral oophorectomy for removal of uterus and/or ovaries).
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 |
|---|---|---|
| Hyperpolarized 13C-PyruvateAlso: HP 13CGiven intravenously (IV) | Drug | Cohort A (HP 13C pyruvate, MRI), Cohort B (HP 13C pyruvate, MRI) |
| Computed tomography (CT)Also: CTUndergo CT imaging | Procedure or surgery | Cohort A (HP 13C pyruvate, MRI), Cohort B (HP 13C pyruvate, MRI) |
| Magnetic Resonance Imaging (MRI)Also: MRIUndergo MRI imaging | Procedure or surgery | Cohort A (HP 13C pyruvate, MRI), Cohort B (HP 13C pyruvate, MRI) |
Primary outcome
Proportion of participants with best objective response (Cohorts A and B)
Time frame: Up to 24 months
The best objective response based on clinical imaging according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.11 will be reported
Mean percent change in target tumor peak HP 13C lactate/pyruvate ratio over time
Time frame: Up to 6 weeks
The mean percent change in peak HP 13C lactate/pyruvate ratio with 95% confidence intervals (CI) will be reported for scans completed at baseline and after 4 weeks (+/- 2 weeks) of non-interventional, standard of care treatment.
Mean change in target tumor HP 13C lactate/pyruvate area under the curve (AUC) ratio over time
Time frame: Up to 6 weeks
The mean change in HP 13C lactate/pyruvate area under the curve (AUC) ratio will be reported for scans completed at baseline and scans after 4 weeks (+/- 2 weeks) of non-interventional, standard of care treatment.
Mean percent change in target tumor HP 13C pyruvate to lactate conversion rate (kPL).
Time frame: Up to 6 weeks
The mean percent change in pyruvate to lactate conversion rate (kPL) will be reported for scans completed at baseline and scans after 4 weeks (+/- 2 weeks) of non-interventional, standard of care treatment.
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 12 Nov 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.
Zhen Wang, MD principal investigator
University of California, San Francisco
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 Pancreatic Ductal Adenocarcinoma and Metastatic Pancreatic Ductal Adenocarcinoma, run by University of California, San Francisco 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 8 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 12 Nov 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?
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 Louise Magat ((415) 502-1822, Louise.Magat@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with best objective response (Cohorts A and B) (time frame: Up to 24 months). The study lists 4 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 12 Nov 2025.