Breast CarcinomaEarly Phase 1NCT04147494
Experimental PET Imaging Scans Before Cancer Surgery to Study the Amount of PET Tracer Accumulated in Normal and Cancer Tissues
A Early Phase 1 study testing Computed Tomography, Gallium Ga 68 FAPi-46 and Gallium Ga 68-labeled PSMA-11 in people with Breast Carcinoma and Colon Carcinoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
This phase I trial studies a new imaging technique called FAPi PET/CT to determine where and to which degree the FAPI tracer (68Ga-FAPi-46) accumulate in normal and cancer tissues in patients with non-prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Carcinoma, Colon Carcinoma, Esophageal Carcinoma
- What is being tested?
- Computed Tomography, Gallium Ga 68 FAPi-46 and Gallium Ga 68-labeled PSMA-11
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2019to 17 Oct 2031
- Phase
- Early Phase 1
- 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
- Patients with the following cancer types:
- Breast cancer
- Colon cancer
- Esophageal cancer
- Gastric cancer
- Head and Neck cancer
Show all 15Show fewer
- Lung cancer
- Ovarian cancer
- Pancreatic cancer
- Renal cancer
- Uterus cancer
- Patients who are scheduled to undergo surgical resection of the primary tumor and/or metastasis
- Patient can provide written informed consent
- Patient is capable of complying with study procedures
- Patient is able to remain still for duration of imaging procedure (up to one hour)
Who cannot join
- Patient is pregnant or nursing
- Patients with any new cancer therapy between the baseline 18F-FDG PET/CT and the investigational FAPI PET/CT
- Patient has underlying disease which, based on the judgment of the investigator, might interfere with the collection of high quality data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PET Biodistribution Study of 68Ga-PSMA-11 and 68Ga-FAPI-46 in Patients With Non-Prostate Cancers: An Exploratory Biodistribution Study With Histopathology Validation
This phase I trial studies a new imaging technique called FAPi PET/CT to determine where and to which degree the FAPI tracer (68Ga-FAPi-46) accumulate in normal and cancer tissues in patients with non-prostate cancer. The research team also want to know whether what they see on PET/CT images represents the tumor tissue being excised from the patient's body. The research team is also interested to investigate another new imaging technique called PSMA PET/CT. Participants will be invited to undergo another PET/CT scan, with the PSMA tracer (68Ga-PSMA-11). This is not required but just an option for volunteer patients. Patients who have not received an 18F-FDG PET/CT within one month of enrollment will also undergo an FDG PET/CT scan. The PET/CT scanner combines the PET and the CT scanners into a single device. This device combines the anatomic (body structure) information provided by the CT scan with the metabolic information obtained from the PET scan. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of, in the case of this research, 68Ga-PSMA-11 and 68Ga-FAPi, and 18F-FDG (if applicable). Because some cancers take up 68Ga-PSMA-11 and/or 68Ga-FAPi it can be seen with PET. CT utilizes x-rays that traverse the body from the outside. CT images provide an exact outline of organs where it occurs in patient's body. FAP stands for Fibroblast Activation Protein. FAP is produced by cells that surround tumors. The function of FAP is not well understood but imaging studies have shown that FAP can be detected with FAPI PET/CT. Imaging FAP with FAPI PET/CT may in the future provide additional information about various cancers. PSMA stands for Prostate Specific Membrane Antigen. This name is incorrect as PSMA is also found in many other cancers. The function of PSMA is not well understood but imaging studies have shown that PSMA can be detected with PET in many non-prostate cancers. Imaging FAP with PET/CT may in the future provide additional information about various cancers.
Read the detailed description
PRIMARY OBJECTIVE:
- To define the biodistribution of gallium Ga 68 FAPi-46 (68Ga-FAPi-46) and gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) in normal and cancer tissues of patients with various non-prostate malignancies. The goal is to determine where and to which degree 68Ga-FAPi-46 and 68Ga-PSMA-11 accumulates in normal and cancer tissues.
SECONDARY OBJECTIVES:
- To evaluate whether 68Ga-FAPi-46 and 68Ga-PSMA-11 accumulation observed by positron emission tomography (PET) correlates with the amount of fibroblast activation protein (FAP) and prostate specific membrane antigen (PSMA) in excised cancer tissue, respectively.
II. To evaluate the 68Ga-FAPI-46 biodistribution correlation with 18F-FDG biodistribution (when available) to define the frequency of the following phenotypes (FAP+/ FDG+, FAP-/ FDG+, FAP+/ FDG-, FAP-/ FDG-).
EXPERIMENTAL OBJECTIVE:
III. Assess the 68Ga-FAPI-46 biodistribution correlation with 68Ga-PSMA-11, if the patient volunteers for optional scan, and 18F-fluodeoxyglucose (FDG), if any FDG PET/computed tomography (CT) has been performed as standard-of-care.
OUTLINE:
Patients receive 68Ga-FAPi-46 intravenously (IV) and undergo PET/CT scan over 20-50 minutes. On another day, patients receive 18F-FDG and then undergo PET/computed tomography (CT) according to standard of care procedures (if applicable). Patients may also receive 68Ga-PSMA-11 IV and undergo PET/CT scan over 20-50 minutes on a separate day (for volunteer patients only, PSMA PET/CT is optional and not required).
- Conditions
- Breast Carcinoma, Colon Carcinoma, Esophageal Carcinoma, Gastric Carcinoma, Head and Neck Carcinoma, Kidney Carcinoma
- Being tested
- Computed Tomography, Gallium Ga 68 FAPi-46, Gallium Ga 68-labeled PSMA-11, Positron Emission Tomography, 18F-FDG
- Medical subject headings
- Breast Neoplasms, Colonic Neoplasms, Esophageal Neoplasms, Stomach Neoplasms, Carcinoma, Renal Cell, Lung Neoplasms, Ovarian Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computerized Axial Tomography, computerized tomography
Undergo PET/CT scan
Gallium Ga 68 FAPi-46Radiation
Also called 68Ga-FAPi-46, Gallium-68-FAPi-46
Given IV
Gallium Ga 68-labeled PSMA-11Radiation
Also called (68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC, (68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC, (68)Ga-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC, (68)Gallium-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
Given IV
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, positron emission tomography scan
Undergo PET/CT scan
18F-FDGRadiation
Also called 18F-fluorodeoxyglucose
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Basic Science (68Ga-FAPi-46 PET/CT, 68Ga-PSMA-11 PET/CT) | Experimental | Patients receive 68Ga-FAPi-46 intravenously (IV), and then undergo PET/computed tomography (CT) over 20-90 minutes. On another day, patients receive 18F-FDG and then undergo PET/computed tomography (CT) according to standard of care procedures (if applicable). Patients may also receive 68Ga-PSMA-11 IV and undergo PET/CT scan over 20-50 minutes on a separate day (for volunteer patients only, PSMA PET/CT is optional and not required). Receives: Procedure: Computed Tomography; Radiation: Gallium Ga 68 FAPi-46; Radiation: Gallium Ga 68-labeled PSMA-11; Procedure: Positron Emission Tomography; Radiation: 18F-FDG |
What is being measured
The primary outcome is the main question the study is designed to answer.
To define and document the biodistribution of gallium Ga 68 FAPi-46 (68Ga-FAPi-46) and gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) in normal and cancer tissues of patients with various non-prostate malignancies
To quantify tumor tissue and normal background organs positron emission tomography (PET) tracer uptake by semi-quantitative analysis (unit/metrics = standardized uptake values (SUV)). The 68Ga-PSMA-11 and 68Ga-FAPI-46 tracer biodistribution will be described by mean and maximum standardized uptake values (SUVmean and SUVmax).
Measured: 60 minutes after tracer injection
Secondary outcomes (2)
68Ga-FAPi-46 and 68Ga-PSMA-11 accumulation
To evaluate whether 68Ga-FAPi-46 accumulation observed by PET correlates with the amount of FAP in excised cancer tissue as assessed by immunohistochemistry (IHC).
Measured: From date of imaging to date of surgery (range 1-60 days)
evaluate the 68Ga-FAPI-46 biodistribution correlation with 18F-FDG biodistribution
- To evaluate the 68Ga-FAPI-46 biodistribution correlation with 18F-FDG biodistribution (when available) to define the frequency of the following phenotypes (FAP+/ FDG+, FAP-/ FDG+, FAP+/ FDG-, FAP-/ FDG-).
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study start5 Nov 2019
- Primary completion1 Jun 2030 (estimated)
- Study completion17 Oct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Nuclear Medecine and Molecular Imaging
- Responsible party
- Sponsor
- Investigators
- Jeremie Calais, MD, Principal investigator, UCLA / Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04147494
- Sponsor's protocol ID
- 19-000756
- Other IDs
- NCI-2019-07265
- Status last verified
- Aug 2026
- First submitted
- 24 Oct 2019
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Publications
Holzgreve A, Unterrainer LM, Flores K, Lam EC, Mona CE, Czernin J, Shuch BM, Sisk AE Jr, Calais J. FAP Expression in Renal Tumors Assessed by [68Ga]Ga-FAPI-46 PET Imaging and FAP Immunohistochemistry: A Case Series of Six Patients from the Prospective Exploratory Trial NCT04147494. J Nucl Med. 2026 Jan 2;67(1):49-52. doi: 10.2967/jnumed.125.270346.
PubMed 41101974Kunikowska J, Bizon M, Pelka K, Derlatka P, Olszewski M, Krolicki L. 68 Ga-Prostate-Specific Membrane Antigen PET/CT in Ovarian Tumors : Potential to Differentiate Benign and Malignant Tumors Before Surgery: A Preliminary Report. Clin Nucl Med. 2023 Feb 1;48(2):e60-e66. doi: 10.1097/RLU.0000000000004486. Epub 2022 Nov 18.
PubMed 36512649
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET Biodistribution Study of 68Ga-PSMA-11 and 68Ga-FAPI-46 in Patients With Non-Prostate Cancers: An Exploratory Biodistribution Study With Histopathology Validation
- ClinicalTrials.gov ID
- NCT04147494
- Acronym / sponsor ID
- 19-000756
- Conditions
- Breast Carcinoma, Colon Carcinoma, Esophageal Carcinoma, Gastric Carcinoma, Head and Neck Carcinoma, Kidney Carcinoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Society of Nuclear Medecine and Molecular Imaging
- Study start
- 5 Nov 2019 (actual)
- Primary completion
- 1 Jun 2030 (estimated)
- Study completion
- 17 Oct 2031 (estimated)
- First posted
- 1 Nov 2019 (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 phase I trial studies a new imaging technique called FAPi PET/CT to determine where and to which degree the FAPI tracer (68Ga-FAPi-46) accumulate in normal and cancer tissues in patients with non-prostate cancer. The research team also want to know whether what they see on PET/CT images represents the tumor tissue being excised from the patient's body. The research team is also interested to investigate another new imaging technique called PSMA PET/CT. Participants will be invited to undergo another PET/CT scan, with the PSMA tracer (68Ga-PSMA-11). This is not required but just an option for volunteer patients. Patients who have not received an 18F-FDG PET/CT within one month of enrollment will also undergo an FDG PET/CT scan. The PET/CT scanner combines the PET and the CT scanners into a single device. This device combines the anatomic (body structure) information provided by the CT scan with the metabolic information obtained from the PET scan. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of, in the case of this research, 68Ga-PSMA-11 and 68Ga-FAPi, and 18F-FDG (if applicable). Because some cancers take up 68Ga-PSMA-11 and/or 68Ga-FAPi it can be seen with PET. CT utilizes x-rays that traverse the body from the outside. CT images provide an exact outline of organs where it occurs in patient's body. FAP stands for Fibroblast Activation Protein. FAP is produced by cells that surround tumors. The function of FAP is not well understood but imaging studies have shown that FAP can be detected with FAPI PET/CT. Imaging FAP with FAPI PET/CT may in the future provide additional information about various cancers. PSMA stands for Prostate Specific Membrane Antigen. This name is incorrect as PSMA is also found in many other cancers. The function of PSMA is not well understood but imaging studies have shown that PSMA can be detected with PET in many non-prostate cancers. Imaging FAP with PET/CT may in the future provide additional information about various cancers.
Detailed description
PRIMARY OBJECTIVE:
- To define the biodistribution of gallium Ga 68 FAPi-46 (68Ga-FAPi-46) and gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) in normal and cancer tissues of patients with various non-prostate malignancies. The goal is to determine where and to which degree 68Ga-FAPi-46 and 68Ga-PSMA-11 accumulates in normal and cancer tissues.
SECONDARY OBJECTIVES:
- To evaluate whether 68Ga-FAPi-46 and 68Ga-PSMA-11 accumulation observed by positron emission tomography (PET) correlates with the amount of fibroblast activation protein (FAP) and prostate specific membrane antigen (PSMA) in excised cancer tissue, respectively.
II. To evaluate the 68Ga-FAPI-46 biodistribution correlation with 18F-FDG biodistribution (when available) to define the frequency of the following phenotypes (FAP+/ FDG+, FAP-/ FDG+, FAP+/ FDG-, FAP-/ FDG-).
EXPERIMENTAL OBJECTIVE:
III. Assess the 68Ga-FAPI-46 biodistribution correlation with 68Ga-PSMA-11, if the patient volunteers for optional scan, and 18F-fluodeoxyglucose (FDG), if any FDG PET/computed tomography (CT) has been performed as standard-of-care.
OUTLINE:
Patients receive 68Ga-FAPi-46 intravenously (IV) and undergo PET/CT scan over 20-50 minutes. On another day, patients receive 18F-FDG and then undergo PET/computed tomography (CT) according to standard of care procedures (if applicable). Patients may also receive 68Ga-PSMA-11 IV and undergo PET/CT scan over 20-50 minutes on a separate day (for volunteer patients only, PSMA PET/CT is optional and not required).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Basic Science (68Ga-FAPi-46 PET/CT, 68Ga-PSMA-11 PET/CT) | Experimental | Procedure: Computed Tomography, Radiation: Gallium Ga 68 FAPi-46, Radiation: Gallium Ga 68-labeled PSMA-11, Procedure: Positron Emission Tomography, Radiation: 18F-FDGPatients receive 68Ga-FAPi-46 intravenously (IV), and then undergo PET/computed tomography (CT) over 20-90 minutes. On another day, patients receive 18F-FDG and then undergo PET/computed tomography (CT) according to standard of care procedures (if applicable). Patients may also receive 68Ga-PSMA-11 IV and undergo PET/CT scan over 20-50 minutes on a separate day (for volunteer patients only, PSMA PET/CT is optional and not required). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients with the following cancer types:
- Patients who are scheduled to undergo surgical resection of the primary tumor and/or metastasis
- Patient can provide written informed consent
- Patient is capable of complying with study procedures
- Patient is able to remain still for duration of imaging procedure (up to one hour)
Key exclusion criteria (3 listed)
- Patient is pregnant or nursing
- Patients with any new cancer therapy between the baseline 18F-FDG PET/CT and the investigational FAPI PET/CT
- Patient has underlying disease which, based on the judgment of the investigator, might interfere with the collection of high quality data
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 |
|---|---|---|
| Computed TomographyAlso: CAT, CAT Scan, Computerized Axial Tomography, computerized tomographyUndergo PET/CT scan | Procedure or surgery | Basic Science (68Ga-FAPi-46 PET/CT, 68Ga-PSMA-11 PET/CT) |
| Gallium Ga 68 FAPi-46Also: 68Ga-FAPi-46, Gallium-68-FAPi-46Given IV | Radiation | Basic Science (68Ga-FAPi-46 PET/CT, 68Ga-PSMA-11 PET/CT) |
| Gallium Ga 68-labeled PSMA-11Also: (68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC, (68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC, (68)Ga-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC, (68)Gallium-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CCGiven IV | Radiation | Basic Science (68Ga-FAPi-46 PET/CT, 68Ga-PSMA-11 PET/CT) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, positron emission tomography scanUndergo PET/CT scan | Procedure or surgery | Basic Science (68Ga-FAPi-46 PET/CT, 68Ga-PSMA-11 PET/CT) |
| 18F-FDGAlso: 18F-fluorodeoxyglucoseGiven IV | Radiation | Basic Science (68Ga-FAPi-46 PET/CT, 68Ga-PSMA-11 PET/CT) |
Primary outcome
To define and document the biodistribution of gallium Ga 68 FAPi-46 (68Ga-FAPi-46) and gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) in normal and cancer tissues of patients with various non-prostate malignancies
Time frame: 60 minutes after tracer injection
To quantify tumor tissue and normal background organs positron emission tomography (PET) tracer uptake by semi-quantitative analysis (unit/metrics = standardized uptake values (SUV)). The 68Ga-PSMA-11 and 68Ga-FAPI-46 tracer biodistribution will be described by mean and maximum standardized uptake values (SUVmean and SUVmax).
2 secondary outcomes
68Ga-FAPi-46 and 68Ga-PSMA-11 accumulation
Time frame: From date of imaging to date of surgery (range 1-60 days)
evaluate the 68Ga-FAPI-46 biodistribution correlation with 18F-FDG biodistribution
Time frame: up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Derived from this study: PubMed 41101974Holzgreve A, Unterrainer LM, Flores K, Lam EC, Mona CE, Czernin J, Shuch BM, Sisk AE Jr, Calais J. FAP Expression in Renal Tumors Assessed by [68Ga]Ga-FAPI-46 PET Imaging and FAP Immunohistochemistry: A Case Series of Six Patients from the Prospective Exploratory Trial NCT04147494. J Nucl Med. 2026 Jan 2;67(1):49-52. doi: 10.2967/jnumed.125.270346.
- Derived from this study: PubMed 36512649Kunikowska J, Bizon M, Pelka K, Derlatka P, Olszewski M, Krolicki L. 68 Ga-Prostate-Specific Membrane Antigen PET/CT in Ovarian Tumors : Potential to Differentiate Benign and Malignant Tumors Before Surgery: A Preliminary Report. Clin Nucl Med. 2023 Feb 1;48(2):e60-e66. doi: 10.1097/RLU.0000000000004486. Epub 2022 Nov 18.
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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.
Jeremie Calais, MD principal investigator
UCLA / Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Computed Tomography, Gallium Ga 68 FAPi-46 and Gallium Ga 68-labeled PSMA-11 in people with Breast Carcinoma and Colon Carcinoma, run by Jonsson Comprehensive Cancer Center 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 15 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: under way, not looking for participants, as of the sponsor's last update on 21 Aug 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
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?
To define and document the biodistribution of gallium Ga 68 FAPi-46 (68Ga-FAPi-46) and gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) in normal and cancer tissues of patients with various non-prostate malignancies (time frame: 60 minutes after tracer injection). 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 NCT04147494, which also lists 2 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 21 Aug 2026; AzTrials last refreshed its copy on 4 Nov 2026.