Primary Breast CancerUltra3DetectNCT04468113
Clip Marker Placement in Primary Lesions of Breast Cancer Patients Receiving Neoadjuvant Therapy
An observational study of Primary Breast Cancer, run by Kliniken Essen-Mitte at 1 site in Germany.
Trial summary
Neoadjuvant systemic therapy (NST) is increasingly recommended for patients with early breast cancer, and the rate of patients with pathological complete remission (pCR) is increasing due to the use of modern chemotherapy regimens and targeted therapies, especially in patients with human epidermal growth factor… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Primary Breast Cancer
- What is being tested?
- Tumark® Vision clip
- Type of treatment
- Medical device
- How many people
- 339 participants
- Where
- 1 siteGermany
- Study dates
- 14 May 2020to 30 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female patients with sonographically suspicious unilateral or bilateral intramammary foci, scheduled for sonography-guided core biopsy and marking of the lesion with the Tumark® Vision Clip.
Who may be able to join
- female patient aged ≥ 18 years
- written informed consent
- patient's consent to NST
- suspicious unilateral or bilateral intramammary foci that can be safely identified by ultrasound
- no evidence of distant metastasis (complete staging does not have to be present at inclusion)
- indication for breast conserving therapy
Show all 10Show fewer
- no prior clip placement in the confirmed intramammary carcinoma
- patient is able to undergo NST treatment (even if the indication based on tumor biology is not yet available)
- high compliance and high number of planned relevant surgical interventions in participating study center
- patient can understand the scope of this prospective registry study
Who cannot join
- allergy to titanium and/or nickel
- pregnancy
- ipsilateral relapse (when NST: no exclusion criterion)
- prior extensive breast surgery (starting from quadrant resection)
- inflammatory breast cancer
- extramammary breast cancer
Show all 10Show fewer
- multicentric or multifocal breast cancer
- patient is not operable
- patient is already undergoing adjuvant/neoadjuvant therapy
- inability to understand the purpose of the clinical trial or to comply with study procedures
Trial locations and contacts
1 site in 1 country.
Germany1 site
Interdisciplinary Breast Unit, Kliniken Essen-Mitte
Essen, 45136
About this study
Official title: Prospective, Multicenter Registry Study Evaluating the Feasibility of Ultrasound-guided Clipping of Suspicious Intramammary Lesions in Primary Breast Cancer Patients Receiving Neoadjuvant Therapy (Ultra3Detect)
Neoadjuvant systemic therapy (NST) is increasingly recommended for patients with early breast cancer, and the rate of patients with pathological complete remission (pCR) is increasing due to the use of modern chemotherapy regimens and targeted therapies, especially in patients with human epidermal growth factor receptor 2 positive (HER2+) breast cancer and triple negative breast cancer (TNBC). It is therefore important to mark a lesion (with e.g. clip) before the start of NST in order to safely identify and localize a clip and (former) tumor bed after completion of NST. Reliable sonographic detection of the clip would be preferred to mammography-guided detection and marking. In addition to avoiding radiation exposure by mammography and reducing time, personnel and financial expenditure, ultrasound-guided wire marking of the clip is less painful for the patient than stereotactic wire marking.
The present prospective registry study aims to evaluate how often the intramammary Tumark® Vision clip can be detected by ultrasound after completion of NST in patients with TNBC and HER2+ breast cancer and thus, in the case of pCR, how often the elaborate clipping with mammographic (stereotactic) guidance can be avoided.
Read the detailed description
Breast cancer patients whose carcinomas have an aggressive tumor biology which implies the need for chemotherapy are increasingly being treated with NST. As a standard procedure, clip placement of the suspicious lesion is performed after ultrasound-guided core biopsy or mammography-guided vacuum biopsy. Clipping is necessary to enable the clear identification of the sonographically suspicious area of the breast and safe surgical removal of the remaining tumor tissue (if any) during a later surgery, even following a good response under NST. The placement of a marker (clip) is particularly important for the precise localization of the original tumor bed in patients with pCR.
There are a number of commercially available markers (clips) which are indicated for intramammary marking of a lesion and which differ in terms of shape and material. Difficulties may arise in placing the clip in the tumor or the tumor center. In addition, the clip can dislocate from the initial location and/or the clip might not be visualized during response monitoring. Evaluations of the ultrasound-visible clip made of nitinol investigated in this study showed very good results regarding marker dislocation and visibility within 7 days after inital placement.The clip, which immediately unfolds into a 3-dimensional spherical structure after insertion into the tissue, could be detected by both sonography and mammography in all 50 cases after the intervention; however, long-term data data at follow-up controls during and after NST are not available so far.
According to current German guidelines, imaging-assisted wire marking is recommended without restriction before breast conserving surgery for non-palpable lesions. The clip is considered the target lesion for wire marking, which can be done under sonographic or stereotactic control. If the clip is reliably visible on ultrasound (even in patients with pCR), the stereotactic control of wire marking can be omitted. Therefore, the ability to visualize a clip in breast ultrasonography is of great importance.
The present multicenter study aims to evaluate the sonographic detection rate of the intramammary Tumark® Vision clips after NST in clinical routine and the proportion of cases in which the clip cannot be detected, and thus the rate of mammography-guided wire markings.
- Conditions
- Primary Breast Cancer
- Being tested
- Tumark® Vision clip
- Keywords
- breast cancer, clip, ultrasound, neoadjuvant therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumark® Vision clipDevice
Suspicious intramammary lesion is marked with clip
| Study group | Role | What they receive |
|---|---|---|
| US-guided core biopsy and clip placement | Female patients with sonographically suspicious, intramammary foci, scheduled for ultrasound-guided core biopsy and marking of the lesion with the Tumark® Vision Clip Receives: Device: Tumark® Vision clip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sonographic detection rate of clip at the time of surgery after completion of NST
Intraoperative detection rate of the clip in patients with HER2+ breast cancer or TNBC after at least 12 weeks of NST treatment
Measured: At the time of surgery
Secondary outcomes (14)
Number of ultrasound-guided clip placements per patient
- Number of lesions marked with a clip per patient and b) Number of clips per lesion
Measured: Immediately after placement of clip
Rate of successful clip placements in the tumor center
Not successful: clip placement technically not possible or clip was placed outside the tumor (indication of the distance from the tumor center in mm)
Measured: Immediately after placement of clip
Visibility of the device (Tumark® Vision) cannula
Visibility (very good, good, sufficient or bad) of the cannula during US-guided clip placement
Measured: During placement of clip
Complications associated with the application of the clip
e.g. hematoma, infection, dislocation, pain (in patients with or without NST)
Measured: Up to 6 months after placement of clip
Sonographic detection rate of clips in patients receiving NST
Detection rate at different time points in all patients receiving NST
Measured: Immediately after placement of clip as well as after 4-8, 9-12, 13-26 weeks of NST treatment and preoperatively
Sonographic detection rate of clips in TNBC and HER2+ patients receiving NST
Detection rate at different time points in TNBC or HER2+ breast cancer receiving NST
Measured: Immediately after clip placement as well as after 4-8, 9-12, 13-26 weeks of NST treatment and preoperatively
Sonographic detection rate of clips in all patients receiving NST and with pCR
Definition of pCR according to residual cancer burden (RCB) score
Measured: Immediately after clip placement as well as after 4-8, 9-12,13-26 weeks of NST treatment and preoperatively
Sonographic detection rate of clips in patients not receiving NST
Subgroup of study population not receiving NST
Measured: Immediately after clip placement and preoperatively
Intraoperative detection rate of the clip in specimen radiographs
Detection of clip in surgical specimen from the breast subjected to radiography
Measured: At the time of surgery
Intraoperative detection rate of the clip on specimen utrasound images
Detection of clip in surgical specimen from the breast subjected to ultrasonography
Measured: At the time of surgery
Proportion of patients requiring preoperative, mammography-guided wire marking
If ultrasound-guided wire marking is not feasible, mammography-guided wire marking is performed
Measured: Preoperatively
Proportion of patients with mammographic verification after sonographic wire-marking
If ultrasound-guided wire marking is inconclusive
Measured: Preoperatively
Proportion of patients with artifacts caused by clips
On ultrasound and/or mammography images
Measured: Up to 6 months after placement of clip
Number of patients with complete pathological remission
ypT0/is, ypN0 status after histological evaluation (according to Residual Cancer Burden [RCB] score) of Symmans (2007)
Measured: Up to 10 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start14 May 2020
- Primary completion30 Mar 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Primary Breast CancerStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 339 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kliniken Essen-Mitte
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sherko Kuemmel, MD, PhD, Principal investigator, Interdisciplinary Breast Unit, Kliniken Essen-Mitte, GermanyMattea Reinisch, MD, Study chair, Interdisciplinary Breast Unit, Kliniken Essen-Mitte, GermanyJörg Heil, MD, PhD, Study chair, Department of Gynecology, Breast Center, Heidelberg University, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04468113
- Sponsor's protocol ID
- V2_16-04-2020
- Acronym
- Ultra3Detect
- Status last verified
- Nov 2023
- First submitted
- 23 Jun 2020
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ruland AM, Hagemann F, Reinisch M, Holtschmidt J, Kummel A, Dittmer-Grabowski C, Stoblen F, Rotthaus H, Dreesmann V, Blohmer JU, Kummel S. Using a New Marker Clip System in Breast Cancer: Tumark Vision(R) Clip - Feasibility Testing in Everyday Clinical Practice. Breast Care (Basel). 2018 Apr;13(2):116-120. doi: 10.1159/000486388. Epub 2018 Mar 9.
PubMed 29887788Hurvitz SA, Martin M, Symmans WF, Jung KH, Huang CS, Thompson AM, Harbeck N, Valero V, Stroyakovskiy D, Wildiers H, Campone M, Boileau JF, Beckmann MW, Afenjar K, Fresco R, Helms HJ, Xu J, Lin YG, Sparano J, Slamon D. Neoadjuvant trastuzumab, pertuzumab, and chemotherapy versus trastuzumab emtansine plus pertuzumab in patients with HER2-positive breast cancer (KRISTINE): a randomised, open-label, multicentre, phase 3 trial. Lancet Oncol. 2018 Jan;19(1):115-126. doi: 10.1016/S1470-2045(17)30716-7. Epub 2017 Nov 23.
PubMed 29175149von Minckwitz G, Untch M, Blohmer JU, Costa SD, Eidtmann H, Fasching PA, Gerber B, Eiermann W, Hilfrich J, Huober J, Jackisch C, Kaufmann M, Konecny GE, Denkert C, Nekljudova V, Mehta K, Loibl S. Definition and impact of pathologic complete response on prognosis after neoadjuvant chemotherapy in various intrinsic breast cancer subtypes. J Clin Oncol. 2012 May 20;30(15):1796-804. doi: 10.1200/JCO.2011.38.8595. Epub 2012 Apr 16.
PubMed 22508812Shah AD, Mehta AK, Talati N, Brem R, Margolies LR. Breast tissue markers: Why? What's out there? How do I choose? Clin Imaging. 2018 Nov-Dec;52:123-136. doi: 10.1016/j.clinimag.2018.07.003. Epub 2018 Jul 6.
PubMed 30059952
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter Registry Study Evaluating the Feasibility of Ultrasound-guided Clipping of Suspicious Intramammary Lesions in Primary Breast Cancer Patients Receiving Neoadjuvant Therapy (Ultra3Detect)
- ClinicalTrials.gov ID
- NCT04468113
- Acronym / sponsor ID
- Ultra3Detect / V2_16-04-2020
- Conditions
- Primary Breast Cancer
- Keywords
- breast cancer, clip, ultrasound, neoadjuvant therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 339 participants (actual)
- Lead sponsor
- Kliniken Essen-MitteUniversity, hospital or other
- Study start
- 14 May 2020 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 13 Jul 2020 (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.
Neoadjuvant systemic therapy (NST) is increasingly recommended for patients with early breast cancer, and the rate of patients with pathological complete remission (pCR) is increasing due to the use of modern chemotherapy regimens and targeted therapies, especially in patients with human epidermal growth factor receptor 2 positive (HER2+) breast cancer and triple negative breast cancer (TNBC). It is therefore important to mark a lesion (with e.g. clip) before the start of NST in order to safely identify and localize a clip and (former) tumor bed after completion of NST. Reliable sonographic detection of the clip would be preferred to mammography-guided detection and marking. In addition to avoiding radiation exposure by mammography and reducing time, personnel and financial expenditure, ultrasound-guided wire marking of the clip is less painful for the patient than stereotactic wire marking.
The present prospective registry study aims to evaluate how often the intramammary Tumark® Vision clip can be detected by ultrasound after completion of NST in patients with TNBC and HER2+ breast cancer and thus, in the case of pCR, how often the elaborate clipping with mammographic (stereotactic) guidance can be avoided.
Detailed description
Breast cancer patients whose carcinomas have an aggressive tumor biology which implies the need for chemotherapy are increasingly being treated with NST. As a standard procedure, clip placement of the suspicious lesion is performed after ultrasound-guided core biopsy or mammography-guided vacuum biopsy. Clipping is necessary to enable the clear identification of the sonographically suspicious area of the breast and safe surgical removal of the remaining tumor tissue (if any) during a later surgery, even following a good response under NST. The placement of a marker (clip) is particularly important for the precise localization of the original tumor bed in patients with pCR.
There are a number of commercially available markers (clips) which are indicated for intramammary marking of a lesion and which differ in terms of shape and material. Difficulties may arise in placing the clip in the tumor or the tumor center. In addition, the clip can dislocate from the initial location and/or the clip might not be visualized during response monitoring. Evaluations of the ultrasound-visible clip made of nitinol investigated in this study showed very good results regarding marker dislocation and visibility within 7 days after inital placement.The clip, which immediately unfolds into a 3-dimensional spherical structure after insertion into the tissue, could be detected by both sonography and mammography in all 50 cases after the intervention; however, long-term data data at follow-up controls during and after NST are not available so far.
According to current German guidelines, imaging-assisted wire marking is recommended without restriction before breast conserving surgery for non-palpable lesions. The clip is considered the target lesion for wire marking, which can be done under sonographic or stereotactic control. If the clip is reliably visible on ultrasound (even in patients with pCR), the stereotactic control of wire marking can be omitted. Therefore, the ability to visualize a clip in breast ultrasonography is of great importance.
The present multicenter study aims to evaluate the sonographic detection rate of the intramammary Tumark® Vision clips after NST in clinical routine and the proportion of cases in which the clip cannot be detected, and thus the rate of mammography-guided wire markings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| US-guided core biopsy and clip placement | – | Device: Tumark® Vision clipFemale patients with sonographically suspicious, intramammary foci, scheduled for ultrasound-guided core biopsy and marking of the lesion with the Tumark® Vision Clip |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients with sonographically suspicious unilateral or bilateral intramammary foci, scheduled for sonography-guided core biopsy and marking of the lesion with the Tumark® Vision Clip.
Key inclusion criteria (10 listed)
- female patient aged ≥ 18 years
- written informed consent
- patient's consent to NST
- suspicious unilateral or bilateral intramammary foci that can be safely identified by ultrasound
- no evidence of distant metastasis (complete staging does not have to be present at inclusion)
Key exclusion criteria (10 listed)
- allergy to titanium and/or nickel
- pregnancy
- ipsilateral relapse (when NST: no exclusion criterion)
- prior extensive breast surgery (starting from quadrant resection)
- inflammatory breast 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 |
|---|---|---|
| Tumark® Vision clipSuspicious intramammary lesion is marked with clip | Device | US-guided core biopsy and clip placement |
Primary outcome
Sonographic detection rate of clip at the time of surgery after completion of NST
Time frame: At the time of surgery
Intraoperative detection rate of the clip in patients with HER2+ breast cancer or TNBC after at least 12 weeks of NST treatment
14 secondary outcomes
Number of ultrasound-guided clip placements per patient
Time frame: Immediately after placement of clip
Rate of successful clip placements in the tumor center
Time frame: Immediately after placement of clip
Visibility of the device (Tumark® Vision) cannula
Time frame: During placement of clip
Complications associated with the application of the clip
Time frame: Up to 6 months after placement of clip
Sonographic detection rate of clips in patients receiving NST
Time frame: Immediately after placement of clip as well as after 4-8, 9-12, 13-26 weeks of NST treatment and preoperatively
Sonographic detection rate of clips in TNBC and HER2+ patients receiving NST
Time frame: Immediately after clip placement as well as after 4-8, 9-12, 13-26 weeks of NST treatment and preoperatively
Sonographic detection rate of clips in all patients receiving NST and with pCR
Time frame: Immediately after clip placement as well as after 4-8, 9-12,13-26 weeks of NST treatment and preoperatively
Sonographic detection rate of clips in patients not receiving NST
Time frame: Immediately after clip placement and preoperatively
Intraoperative detection rate of the clip in specimen radiographs
Time frame: At the time of surgery
Intraoperative detection rate of the clip on specimen utrasound images
Time frame: At the time of surgery
Proportion of patients requiring preoperative, mammography-guided wire marking
Time frame: Preoperatively
Proportion of patients with mammographic verification after sonographic wire-marking
Time frame: Preoperatively
Proportion of patients with artifacts caused by clips
Time frame: Up to 6 months after placement of clip
Number of patients with complete pathological remission
Time frame: Up to 10 weeks after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Background: PubMed 29887788Ruland AM, Hagemann F, Reinisch M, Holtschmidt J, Kummel A, Dittmer-Grabowski C, Stoblen F, Rotthaus H, Dreesmann V, Blohmer JU, Kummel S. Using a New Marker Clip System in Breast Cancer: Tumark Vision(R) Clip - Feasibility Testing in Everyday Clinical Practice. Breast Care (Basel). 2018 Apr;13(2):116-120. doi: 10.1159/000486388. Epub 2018 Mar 9.
- Background: PubMed 29175149Hurvitz SA, Martin M, Symmans WF, Jung KH, Huang CS, Thompson AM, Harbeck N, Valero V, Stroyakovskiy D, Wildiers H, Campone M, Boileau JF, Beckmann MW, Afenjar K, Fresco R, Helms HJ, Xu J, Lin YG, Sparano J, Slamon D. Neoadjuvant trastuzumab, pertuzumab, and chemotherapy versus trastuzumab emtansine plus pertuzumab in patients with HER2-positive breast cancer (KRISTINE): a randomised, open-label, multicentre, phase 3 trial. Lancet Oncol. 2018 Jan;19(1):115-126. doi: 10.1016/S1470-2045(17)30716-7. Epub 2017 Nov 23.
- Background: PubMed 22508812von Minckwitz G, Untch M, Blohmer JU, Costa SD, Eidtmann H, Fasching PA, Gerber B, Eiermann W, Hilfrich J, Huober J, Jackisch C, Kaufmann M, Konecny GE, Denkert C, Nekljudova V, Mehta K, Loibl S. Definition and impact of pathologic complete response on prognosis after neoadjuvant chemotherapy in various intrinsic breast cancer subtypes. J Clin Oncol. 2012 May 20;30(15):1796-804. doi: 10.1200/JCO.2011.38.8595. Epub 2012 Apr 16.
- Background: PubMed 30059952Shah AD, Mehta AK, Talati N, Brem R, Margolies LR. Breast tissue markers: Why? What's out there? How do I choose? Clin Imaging. 2018 Nov-Dec;52:123-136. doi: 10.1016/j.clinimag.2018.07.003. Epub 2018 Jul 6.
- Individual participant dataSharing planned: No
Related trials for Primary Breast Cancer
RecruitingObservational study
Preoperative vs. Pathologic Size in Breast Cancer: A Prospective Study
Mastectomy, Breast Neoplasm Malignant Primary
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Active, not recruitingObservational study
Longitudinal ctDNA Surveillance for Older Women With ER+ Breast Cancer Who Omit Surgery
Breast Cancer
RecruitingPhase 1/2
Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)
High Grade Epithelial Ovarian Cancer, High Grade Serous Ovarian Cancer
Recruiting
Researching the Effect of Exercise on Cancer
Breast Cancer, Prostate Cancer
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.
Sherko Kuemmel, MD, PhD principal investigator
Interdisciplinary Breast Unit, Kliniken Essen-Mitte, Germany
Mattea Reinisch, MD study chair
Interdisciplinary Breast Unit, Kliniken Essen-Mitte, Germany
Jörg Heil, MD, PhD study chair
Department of Gynecology, Breast Center, Heidelberg University, Germany
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 Primary Breast Cancer, run by Kliniken Essen-Mitte at 1 site in Germany.
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 10 inclusion and 10 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: finished, as of the sponsor's last update on 24 Nov 2023. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sonographic detection rate of clip at the time of surgery after completion of NST (time frame: At the time of 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 NCT04468113, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.