Prostate CancerINTROSPECTNCT07829068
Brief Title: INTROSPECT: Intraoperative PSMA PET/CT Imaging During Radical Prostatectomy
A study testing study-specific administration of 68Ga-PSMA-11 followed by ex vivo PET/CT imaging of the prostatectomy specimen in people with Prostate Cancer and PSMA PET/CT, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
During prostate cancer surgery, the surgeon aims to remove the tumor completely while preserving the surrounding tissue responsible for urinary continence and sexual potency. However, during surgery, it can be difficult to distinguish cancerous tissue from surrounding healthy tissue and therefore to determine the… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, PSMA PET/CT, Margin Assessment
- What is being tested?
- study-specific administration of 68Ga-PSMA-11 followed by ex vivo PET/CT imaging of the prostatectomy specimen
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 30 May 2025to 30 Sep 2027
- Phase
- Interventional
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of intermediate- or high-risk prostate cancer.
- Preoperative PSMA PET staging with positive uptake in the primary tumor.
- Multidisciplinary approval by the urology tumor board for radical prostatectomy and study inclusion.
- Capacity to provide informed consent
Who cannot join
- Refusal to participate or withdrawal from the study.
- Inability to follow study procedures, for example because of language difficulties, psychological disorders or dementia.
- Participation in another clinical trial requiring ex vivo prostate tissue for research.
- Prior treatment that may alter PSMA uptake, such as androgen deprivation therapy or radiotherapy.
- Variant prostate cancer histology, such as neuroendocrine cancer.
- Insufficient-quality or unavailable PSMA PET images, including corrupted data, or an incomplete histopathology report.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Hôpitaux Universitaires de Genève - Dept de Chirurgie - Service d'Urologie
Geneva, Canton of Geneva, 1205
About this study
Official title: INTROSPECT: INTRa-Operative PSMA-PET/CT for Radical Prostatectomy - A Pilot Study
During prostate cancer surgery, the surgeon aims to remove the tumor completely while preserving the surrounding tissue responsible for urinary continence and sexual potency. However, during surgery, it can be difficult to distinguish cancerous tissue from surrounding healthy tissue and therefore to determine the exact extent of the tumor. As a result, cancer cells may sometimes remain at the edge of the removed prostate, resulting in what is known as a positive surgical margin. Currently, positive surgical margins are identified by histopathology of the prostate specimen, with the results becoming available several days after surgery.
The long-term goal of intraoperative imaging is to provide surgeons with information about tumor extent and surgical margins while the operation is still ongoing. This information could allow surgeons to remove additional cancerous tissue during the same procedure while helping preserve surrounding healthy structures. This pilot study INTROSPECT is an initial step toward this goal.
Read more
INTROSPECT is a prospective pilot study at Geneva University Hospitals evaluating a PET/CT Scanner (AURA-10, Xeos Medical, Belgium) to analyze the prostate specimen directly in the operating room (results in 12 minutes). We plan to include 30 participants. All participants will receive an injection of a radiotracer ([68Ga]Ga-PSMA-11) at the beginning of surgery. Images will then be compared with the microscopic evaluation to find out how accurately they show the location and extent of the cancer.
In this pilot study, the PET/CT findings will not be used to modify the surgical procedure or to remove additional tissue. The study is designed to determine whether the technique is sufficiently accurate and feasible to support future studies evaluating its use for real-time surgical decision-making.
The study will also assess radiation exposure to operating room personnel and explore methods for interpreting and segmenting the PET images.
Read the detailed description
Intraoperative Margin Assessment (IMA) in Robotic-Assisted Radical Prostatectomy (RARP) has the potential to reduce the 30% Positive Surgical Margin (PSM) rate.
Nevertheless, the leading technique, NeuroSAFE, is based on the intraoperative frozen section (IFS) of the lateral halves of the prostate, which, despite demonstrated oncological benefits, has several drawbacks. First, implementation is largely restricted to specialized centers as it requires dedicated pathology equipment (cryostat) and a uropathologist team trained in the technique. Secondly, apical and basal regions are not assessed, therefore missing potential margins, frequently located in the apex. Finally, results are obtained in 45 minutes, potentially increasing operating time.
In this context, intraoperative PSMA-PET margin assessment has been recently introduced using the CE-marked AURA-10 Device (Xeos Medical, Belgium), which can provide results within 12 minutes. Several previous studies confirmed the feasibility of the procedure in oncological settings. Regarding prostate cancer, only patients presenting high-risk prostate cancer were included, with a detection of 67% to 100% of PSM. Unfortunately, available evidence remains preliminary, with several aspects requiring further investigation (which populations can benefit from the technology, validation against histopathology, image interpretation [inter-reader agreement, segmentation methods] …). Also, clinical implementation requires a characterization of staff radiation exposure and residual specimen activity.
To address these questions, we designed INTROSPECT, a prospective IDEAL Stage 2a, single center, pilot study at Geneva University Hospitals. We aim to enroll 30 patients with intermediate or high-risk prostate cancer (PCa) scheduled for RARP. Eligibility requires uptake of the index lesion on preoperative PSMA PET imaging and an indication for radical prostatectomy after multidisciplinary Tumor Board presentation. Participants will undergo RARP with lymph node dissection when clinically indicated. The research procedures include intraoperative intravenous administration of gallium-68 PSMA-11 at 1.0 MBq/kg. The freshly resected prostate is placed in a dedicated holder and scanned in the operating room. The primary objective is to evaluate the concordance between ex-vivo PSMA and final histopathology. Secondary objectives include image interpretability evaluation and concordance with preoperative imaging modalities. We will also evaluate occupational exposure and residual specimen activity.
- Conditions
- Prostate Cancer, PSMA PET/CT, Margin Assessment
- Being tested
- study-specific administration of 68Ga-PSMA-11 followed by ex vivo PET/CT imaging of the prostatectomy specimen
- Keywords
- Prostatectomy, Positron Emission Tomography Computed Tomography, Intraoperative care
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
study-specific administration of 68Ga-PSMA-11 followed by ex vivo PET/CT imaging of the prostatectomy specimenRadiation
Single intravenous injection of 1.0 MBq/kg Gallium-PSMA, administered during surgery (docking phase). PET/CT imaging of the freshly resected prostate specimen in the operating room using the AURA 10 device.
| Study group | Role | What they receive |
|---|---|---|
| Participants with prostate cancer undergoing robot-assisted radical prostatectomy. | Experimental | Adult men with intermediate or high-risk prostate cancer with a PSMA -avid tumor (preoperative PET imaging) and a multidisciplinary indication for radical prostatectomy. Reference Standard is the histopathological analysis. No intraoperative re-resection is performed based on intraoperative results Receives: Radiation: study-specific administration of 68Ga-PSMA-11 followed by ex vivo PET/CT imaging of the prostatectomy specimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance between ex vivo PSMA PET/CT imaging and histopathology
Concordance between intraoperative ex vivo PSMA PET/CT imaging and the final histopathological analysis/results of the prostate specimen including positive surgical margin assessment and lesion-by-lesion analysis (tumor extent).
Measured: Day 0 (surgery) - From intravenous injection (Gallium PSMA), PET-PSMA, prostatectomy, through histopathological results (Day 10 post-surgery).
Secondary outcomes (4)
Radiation exposure of operating room staff
Operating Room Staff (senior attending surgeon, fellow, scrub nurse, bedside assistant, circulating nurse, anaesthesiologist, installation technician) will wear Electronic Personal Dosimeter (DMC 3000™, Mirion Technologies, USA) to assess the Whole-Body Dose, Hp(10). The bedside assistant will also wear an extremity dosimeter (ED3, Rotunda Scientific Technologies LLC, USA) to measure Hp(0.07).
Measured: Day 0 - prostatectomy
Radioactivity of the prostate specimen
Residual specimen activity will be measured with a High-Purity Germanium Detector.
Measured: Day 0 - prostatectomy
Concordance between in vivo and ex vivo imaging
Concordance in tumor localization and extent between preoperative imaging and intraoperative ex vivo PSMA PET/CT.
Measured: From preoperative imaging (Day -180) to intraoperative ex vivo PSMA PET/CT (Day 1 post-surgery)
Image interpretability and tumor segmentation
Guidance for image interpretation, different tumor segmentation methods and inter-reader variability.
Measured: From intraoperative ex vivo PSMA PET/CT (Day 0 surgery) to image interpretation (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start30 May 2025
- Primary completion12 Feb 2026
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, single-center, nonrandomized pilot study, IDEAL Stage 2a
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Massimo Valerio, University Hospital, Geneva
- Investigators
- Massimo Valerio, Prof Dr med, Principal investigator, Geneva University Hospitals (HUG)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07829068
- Sponsor's protocol ID
- 2025-00458
- Other IDs
- 2025
- Acronym
- INTROSPECT
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual imaging data and pathological data will be available. Data will be provided only for analyses aiming at developping the technique. Study protocol, Statistical Analysis Plan and Statistical Code will be available for anyone requesting it. Proposals should be directed to olivier.windisch@hug.ch
Publications
Moraitis A, Kahl T, Kandziora J, Jentzen W, Kersting D, Pullen L, Reis H, Kollermann J, Kesch C, Krafft U, Hadaschik BA, Zaidi H, Herrmann K, Barbato F, Fendler WP, Darr C, Fragoso Costa P. Evaluation of Surgical Margins with Intraoperative PSMA PET/CT and Their Prognostic Value in Radical Prostatectomy. J Nucl Med. 2025 Mar 3;66(3):352-358. doi: 10.2967/jnumed.124.268719.
PubMed 39915125Oderda M, Grimaldi S, Rovera G, Delsedime L, D'Agate D, Lavagno F, Marquis A, Marra G, Molinaro L, Deandreis D, Gontero P. Robot-assisted PSMA-radioguided Surgery to Assess Surgical Margins and Nodal Metastases in Prostate Cancer Patients: Report on Three Cases Using an Intraoperative PET-CT Specimen Imager. Urology. 2023 Dec;182:e257-e261. doi: 10.1016/j.urology.2023.08.013. Epub 2023 Sep 3.
PubMed 37669707Darr C, Costa PF, Kahl T, Moraitis A, Engel J, Al-Nader M, Reis H, Kollermann J, Kesch C, Krafft U, Maurer T, Kohler D, Klutmann S, Falkenbach F, Kleesiek J, Fendler WP, Hadaschik BA, Herrmann K. Intraoperative Molecular Positron Emission Tomography Imaging for Intraoperative Assessment of Radical Prostatectomy Specimens. Eur Urol Open Sci. 2023 Jun 15;54:28-32. doi: 10.1016/j.euros.2023.05.017. eCollection 2023 Aug.
PubMed 37361199
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INTROSPECT: INTRa-Operative PSMA-PET/CT for Radical Prostatectomy - A Pilot Study
- ClinicalTrials.gov ID
- NCT07829068
- Acronym / sponsor ID
- INTROSPECT / 2025-00458
- Conditions
- Prostate Cancer, PSMA PET/CT, Margin Assessment
- Keywords
- Prostatectomy, Positron Emission Tomography Computed Tomography, Intraoperative care
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 30 May 2025 (actual)
- Primary completion
- 12 Feb 2026 (actual)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 18 Sep 2026 (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.
During prostate cancer surgery, the surgeon aims to remove the tumor completely while preserving the surrounding tissue responsible for urinary continence and sexual potency. However, during surgery, it can be difficult to distinguish cancerous tissue from surrounding healthy tissue and therefore to determine the exact extent of the tumor. As a result, cancer cells may sometimes remain at the edge of the removed prostate, resulting in what is known as a positive surgical margin. Currently, positive surgical margins are identified by histopathology of the prostate specimen, with the results becoming available several days after surgery.
The long-term goal of intraoperative imaging is to provide surgeons with information about tumor extent and surgical margins while the operation is still ongoing. This information could allow surgeons to remove additional cancerous tissue during the same procedure while helping preserve surrounding healthy structures. This pilot study INTROSPECT is an initial step toward this goal.
INTROSPECT is a prospective pilot study at Geneva University Hospitals evaluating a PET/CT Scanner (AURA-10, Xeos Medical, Belgium) to analyze the prostate specimen directly in the operating room (results in 12 minutes). We plan to include 30 participants. All participants will receive an injection of a radiotracer ([68Ga]Ga-PSMA-11) at the beginning of surgery. Images will then be compared with the microscopic evaluation to find out how accurately they show the location and extent of the cancer.
In this pilot study, the PET/CT findings will not be used to modify the surgical procedure or to remove additional tissue. The study is designed to determine whether the technique is sufficiently accurate and feasible to support future studies evaluating its use for real-time surgical decision-making.
The study will also assess radiation exposure to operating room personnel and explore methods for interpreting and segmenting the PET images.
Detailed description
Intraoperative Margin Assessment (IMA) in Robotic-Assisted Radical Prostatectomy (RARP) has the potential to reduce the 30% Positive Surgical Margin (PSM) rate.
Nevertheless, the leading technique, NeuroSAFE, is based on the intraoperative frozen section (IFS) of the lateral halves of the prostate, which, despite demonstrated oncological benefits, has several drawbacks. First, implementation is largely restricted to specialized centers as it requires dedicated pathology equipment (cryostat) and a uropathologist team trained in the technique. Secondly, apical and basal regions are not assessed, therefore missing potential margins, frequently located in the apex. Finally, results are obtained in 45 minutes, potentially increasing operating time.
In this context, intraoperative PSMA-PET margin assessment has been recently introduced using the CE-marked AURA-10 Device (Xeos Medical, Belgium), which can provide results within 12 minutes. Several previous studies confirmed the feasibility of the procedure in oncological settings. Regarding prostate cancer, only patients presenting high-risk prostate cancer were included, with a detection of 67% to 100% of PSM. Unfortunately, available evidence remains preliminary, with several aspects requiring further investigation (which populations can benefit from the technology, validation against histopathology, image interpretation [inter-reader agreement, segmentation methods] …). Also, clinical implementation requires a characterization of staff radiation exposure and residual specimen activity.
To address these questions, we designed INTROSPECT, a prospective IDEAL Stage 2a, single center, pilot study at Geneva University Hospitals. We aim to enroll 30 patients with intermediate or high-risk prostate cancer (PCa) scheduled for RARP. Eligibility requires uptake of the index lesion on preoperative PSMA PET imaging and an indication for radical prostatectomy after multidisciplinary Tumor Board presentation. Participants will undergo RARP with lymph node dissection when clinically indicated. The research procedures include intraoperative intravenous administration of gallium-68 PSMA-11 at 1.0 MBq/kg. The freshly resected prostate is placed in a dedicated holder and scanned in the operating room. The primary objective is to evaluate the concordance between ex-vivo PSMA and final histopathology. Secondary objectives include image interpretability evaluation and concordance with preoperative imaging modalities. We will also evaluate occupational exposure and residual specimen activity.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single-center, nonrandomized pilot study, IDEAL Stage 2a
| Arm | Type | Receives |
|---|---|---|
| Participants with prostate cancer undergoing robot-assisted radical prostatectomy. | Experimental | Radiation: study-specific administration of 68Ga-PSMA-11 followed by ex vivo PET/CT imaging of the prostatectomy specimenAdult men with intermediate or high-risk prostate cancer with a PSMA -avid tumor (preoperative PET imaging) and a multidisciplinary indication for radical prostatectomy. Reference Standard is the histopathological analysis. No intraoperative re-resection is performed based on intraoperative results |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of intermediate- or high-risk prostate cancer.
- Preoperative PSMA PET staging with positive uptake in the primary tumor.
- Multidisciplinary approval by the urology tumor board for radical prostatectomy and study inclusion.
- Capacity to provide informed consent
Key exclusion criteria (6 listed)
- Refusal to participate or withdrawal from the study.
- Inability to follow study procedures, for example because of language difficulties, psychological disorders or dementia.
- Participation in another clinical trial requiring ex vivo prostate tissue for research.
- Prior treatment that may alter PSMA uptake, such as androgen deprivation therapy or radiotherapy.
- Variant prostate cancer histology, such as neuroendocrine cancer.
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 |
|---|---|---|
| study-specific administration of 68Ga-PSMA-11 followed by ex vivo PET/CT imaging of the prostatectomy specimenSingle intravenous injection of 1.0 MBq/kg Gallium-PSMA, administered during surgery (docking phase). PET/CT imaging of the freshly resected prostate specimen in the operating room using the AURA 10 device. | Radiation | Participants with prostate cancer undergoing robot-assisted radical prostatectomy. |
Primary outcome
Concordance between ex vivo PSMA PET/CT imaging and histopathology
Time frame: Day 0 (surgery) - From intravenous injection (Gallium PSMA), PET-PSMA, prostatectomy, through histopathological results (Day 10 post-surgery).
Concordance between intraoperative ex vivo PSMA PET/CT imaging and the final histopathological analysis/results of the prostate specimen including positive surgical margin assessment and lesion-by-lesion analysis (tumor extent).
4 secondary outcomes
Radiation exposure of operating room staff
Time frame: Day 0 - prostatectomy
Radioactivity of the prostate specimen
Time frame: Day 0 - prostatectomy
Concordance between in vivo and ex vivo imaging
Time frame: From preoperative imaging (Day -180) to intraoperative ex vivo PSMA PET/CT (Day 1 post-surgery)
Image interpretability and tumor segmentation
Time frame: From intraoperative ex vivo PSMA PET/CT (Day 0 surgery) to image interpretation (Day 0)
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 30 Sep 2026.
- Background: PubMed 39915125Moraitis A, Kahl T, Kandziora J, Jentzen W, Kersting D, Pullen L, Reis H, Kollermann J, Kesch C, Krafft U, Hadaschik BA, Zaidi H, Herrmann K, Barbato F, Fendler WP, Darr C, Fragoso Costa P. Evaluation of Surgical Margins with Intraoperative PSMA PET/CT and Their Prognostic Value in Radical Prostatectomy. J Nucl Med. 2025 Mar 3;66(3):352-358. doi: 10.2967/jnumed.124.268719.
- Background: PubMed 37669707Oderda M, Grimaldi S, Rovera G, Delsedime L, D'Agate D, Lavagno F, Marquis A, Marra G, Molinaro L, Deandreis D, Gontero P. Robot-assisted PSMA-radioguided Surgery to Assess Surgical Margins and Nodal Metastases in Prostate Cancer Patients: Report on Three Cases Using an Intraoperative PET-CT Specimen Imager. Urology. 2023 Dec;182:e257-e261. doi: 10.1016/j.urology.2023.08.013. Epub 2023 Sep 3.
- Background: PubMed 37361199Darr C, Costa PF, Kahl T, Moraitis A, Engel J, Al-Nader M, Reis H, Kollermann J, Kesch C, Krafft U, Maurer T, Kohler D, Klutmann S, Falkenbach F, Kleesiek J, Fendler WP, Hadaschik BA, Herrmann K. Intraoperative Molecular Positron Emission Tomography Imaging for Intraoperative Assessment of Radical Prostatectomy Specimens. Eur Urol Open Sci. 2023 Jun 15;54:28-32. doi: 10.1016/j.euros.2023.05.017. eCollection 2023 Aug.
- Individual participant dataSharing planned: Yes. Deidentified individual imaging data and pathological data will be available. Data will be provided only for analyses aiming at developping the technique. Study protocol, Statistical Analysis Plan and Statistical Code will be available for anyone requesting it. Proposals should be directed to olivier.windisch@hug.ch
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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.
Massimo Valerio, Prof Dr med principal investigator
Geneva University Hospitals (HUG)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing study-specific administration of 68Ga-PSMA-11 followed by ex vivo PET/CT imaging of the prostatectomy specimen in people with Prostate Cancer and PSMA PET/CT, run by University Hospital, Geneva at 1 site in Switzerland.
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 4 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: under way, not looking for participants, as of the sponsor's last update on 30 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 1 site in Switzerland. 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?
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?
Concordance between ex vivo PSMA PET/CT imaging and histopathology (time frame: Day 0 (surgery) - From intravenous injection (Gallium PSMA), PET-PSMA, prostatectomy, through histopathological results (Day 10 post-surgery).). 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 NCT07829068, which also lists 3 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 30 Sep 2026.