Pancreatic CancerNCT03621644
Stereotactic MRI-guided On-table Adaptive Radiation Therapy (SMART) for Locally Advanced Pancreatic Cancer
A study testing Stereotactic MRI-guided On-table Adaptive Radiation Therapy in people with Pancreatic Cancer, run by Viewray Inc. at 13 sites in 2 countries.
Trial summary
High-dose magnetic resonance imaging (MRI) guided hypofractionated radiation therapy delivered using daily adaptive dose planning has been shown in a retrospective study to result in improved overall survival, relative to patients receiving lower radiation doses, in patients with locally advanced pancreatic cancer… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Stereotactic MRI-guided On-table Adaptive Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 1 Jan 2019to Jan 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed locally advanced adenocarcinoma of the pancreas that is considered unresectable or borderline resectable on institutional standardized criteria of unresectability or medical inoperability. Patients with and without regional adenopathy are eligible as long as lymph nodes are adjacent to primary tumor.
- Greater than or equal to 3 months of systemic chemotherapy
- At least 18 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
- Normal bone marrow and organ function as defined below:
- Absolute neutrophil count ≥ 500/mcL (microliters)
Show all 12Show fewer
- Platelets ≥ 50,000/mcL
- Hemoglobin ≥ 8.0 g/dL (deciliters)
- Total bilirubin ≤ 1.5 x IULN
- Aspartate Aminotransferase AST(SGOT) / Alanine Aminotransferase ALT(SGPT) ≤ 3.0 x Institutional Upper Limit of Normal (IULN)
- Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
- Ability to understand and willingness to sign an Institutional Review Board (IRB) approved written informed consent document (or that of legally authorized representative, if applicable).
Who cannot join
- Distant metastatic disease as assessed by staging positron emission tomography / computed tomography (PET/CT) or CT of the chest and abdomen within 6 weeks of starting radiation therapy
- Carbohydrate antigen (CA19.9) > 500 U/ml.
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.
- Currently receiving any other investigational agents.
- Major surgery within 4 weeks prior to first day of treatment.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
- Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
- Medical/psychological contraindication to magnetic resonance imaging (MRI).
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States12 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Henry Ford Health Sciences
Detroit, Michigan, 48202
Dartmouth-Hitchcock
Lebanon, New Hampshire, 03756
UCLA
Los Angeles, California, 90095
University of Wisconisin
Madison, Wisconsin, 53792
University of Miami
Miami, Florida, 33136
Miami Cancer Institute
Miami, Florida, 33176
Cornell University
New York, New York, 10065
Orlando Health
Orlando, Florida, 32806
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Providence Portland Cancer Center
Portland, Oregon, 97213
Washington University
St Louis, Missouri, 63108
About this study
Official title: Prospective Phase II Study of Stereotactic Magnetic Resonance Imaging (MRI) Guided On-table Adaptive Radiation Therapy (SMART) for Patients With Borderline or Inoperable Locally Advanced Pancreatic Cancer
High-dose magnetic resonance imaging (MRI) guided hypofractionated radiation therapy delivered using daily adaptive dose planning has been shown in a retrospective study to result in improved overall survival, relative to patients receiving lower radiation doses, in patients with locally advanced pancreatic cancer, without increasing the rate of serious gastrointestinal toxicity.
The goal of the proposed trial is to investigative in a controlled, prospective manner the robustness of this outcome, and to track quality of life over a 5-year trial period.
Read the detailed description
Prior stereotactic body radiotherapy (SBRT) experiences for treatment of locally advanced pancreatic cancer entailed either single-fraction or multi-fraction approaches delivering 33 Gray (Gy) in 5 fractions. Excellent tolerance and tumor control has been demonstrated, but median survival remained approximately 14 months. This highlights the strengths and limitations of SBRT to current radiation doses for pancreatic cancer. A prior Washington University institutional study and retrospective review has shown the safety of delivering 67.5 Gy in 15 fractions for inoperable pancreatic cancer using a strict 'isotoxicity' approach of limiting the gastrointestinal (GI) organs at risk (stomach, duodenum, small bowel and large bowel) to 45 Gy to 0.5 cm3 or less. This regimen resulted in no grade 3 or higher GI toxicities, and only one death in the 19 patients with a median follow-up of 15 months. This is significantly improved from prior experiences, where approximately 15 months represents the median survival for most studies of inoperable pancreatic cancer.
A recent retrospective analysis of 42 locally advanced pancreatic cancer patients treated by magnetic resonance imaging (MRI) guided radiation therapy at four institutions (University of California, Los Angeles, University of Wisconsin, Vrije Universiteit Medical Center (VUmc), Amsterdam, and Washington University, St. Louis) demonstrated that high-dose stereotactic body radiotherapy (SBRT) or hypofractionated radiation therapy delivered using daily ADAPTIVE dose planning on an MRI-guided radiotherapy system (MRIdian, ViewRay Inc.) has the potential to further improve overall survival. A control group of 19 patients treated to more conventional radiation doses without frequent dose adaptation showed a median survival of 14.8 months, while patients treated to high radiation doses (n=23, maximum biologically equivalent dose at alpha/beta = 10 Gy, or BED10 of > 90 Gy) under daily or almost daily adaptive re-planning had an estimated median survival of 27.8 months (p=0.005). Interestingly, increased radiation dose delivery using daily dose adaptation was correlated with less grade 3 toxicity (0% in the high dose group vs 15.8% in patients treated to lower radiation doses without dose adaptation).
The compelling data of this retrospective study prompted the development of this current prospective clinical trial designed to assess the primary objective of grade 3 or greater GI toxicity at 90 days for patients with borderline resectable or inoperable locally advanced pancreatic cancer treated with MRI-guided on-table adaptive radiation therapy and soft tissue tracking with radiation beam gating to 50 Gy in 5 fractions. Secondary objectives include assessment of (1) overall survival at 2 years, (2) distant progression free survival at 6 months, and (3) changes in patient-reported quality of life (QOL) from pre-treatment to 3 and 12 months post-treatment.
- Conditions
- Pancreatic Cancer
- Being tested
- Stereotactic MRI-guided On-table Adaptive Radiation Therapy
- Keywords
- Pancreatic Cancer, Radiation Therapy, SBRT
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic MRI-guided On-table Adaptive Radiation TherapyRadiation
Radiation therapy will be delivered with an integrated magnetic resonance imaging (MRI)-guided radiotherapy delivery system (ViewRay MRIdian or MRIdian Linac). The prescribed dose will be 50 Gray (Gy) in 5 fractions. Stereotactic body radiotherapy (SBRT) fractions will be delivered at least twice per week, and with at least 18 hours between fractions. Each participant will be aligned in the treatment system with MRI image-guidance. On-table adaptive re-planning will be used when clinically indicated. In all patients, real-time MRI imaging will be used throughout treatment delivery to monitor the target location and control the radiation beam as necessary.
| Study group | Role | What they receive |
|---|---|---|
| Ablative MRIdian SMART | Experimental | Radiation: Stereotactic MRI-guided On-table Adaptive Radiation Therapy 50 Gy in 5 fractions Receives: Radiation: Stereotactic MRI-guided On-table Adaptive Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal toxicity assessed using Common Terminology Criteria for Adverse Events (CTCAE) v5
Grade 3 or higher gastrointestinal toxicity assessed using Common Terminology Criteria for Adverse Events (CTCAE) v5 within 90 days of completion of radiation therapy
Measured: 90 days
Secondary outcomes (3)
Overall survival
Percentage of patients dying from any cause
Measured: 2 years
Distant progression-free survival
Percentage of patients whose pancreatic cancer does not progress
Measured: 6 months
Patient-reported quality of life (QOL)
Patient-reported assessments using the National Comprehensive Cancer Network (NCCN) Functional Assessment of Cancer Therapy (FACT) Hepatobiliary Symptom Index, 18-item Hepatobiliary Cancer Subscale (FHSI-18) (NCCN FACT FHSI-18)
The FACT FHSI-18 is an 18-item scale, each item answered by patients on a scale of 0 ("not at all") to 4 ("very much"). The Total Scale breaks down into 4 subscales as indicated below:
Total Scale Range: 0-72 (where 72 is good; high scores on each subscale are good)
Disease-Related Symptoms Subscale-Physical (DRS-P): 12 items, score range 0-48
Disease-Related Symptoms Subscale - Emotional (DRS-E): 2 items, score range 0-8
Treatment Side Effects Subscale (TSE): 1 item, score range 0-4
Function and Well-Being Subscale (FWB): 3 items, score range 0-12
To view all the FHSI-18 items, see http://www.facit.org/facitorg/questionnaires
Measured: 3 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start1 Jan 2019
- Primary completion3 Aug 2022
- Study completionJan 2027 (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 Pancreatic 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 133 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Viewray Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Parag J Parikh, MD, Principal investigator, Henry Ford Health SystemPercy Lee, MD, Principal investigator, MD AndersonDaniel Low, PhD, Principal investigator, University of California, Los AngelesMichael Chuong, MD, Principal investigator, Miami Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03621644
- Sponsor's protocol ID
- VR C2T2 - SMART - LAPC/BRPC 1
- Status last verified
- Oct 2022
- First submitted
- 26 Jul 2018
- Last updated
- 14 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Rudra S, Jiang N, Rosenberg SA, Olsen JR, Roach MC, Wan L, Portelance L, Mellon EA, Bruynzeel A, Lagerwaard F, Bassetti MF, Parikh PJ, Lee PP. Using adaptive magnetic resonance image-guided radiation therapy for treatment of inoperable pancreatic cancer. Cancer Med. 2019 May;8(5):2123-2132. doi: 10.1002/cam4.2100. Epub 2019 Apr 1.
PubMed 30932367Parikh PJ, Lee P, Low DA, Kim J, Mittauer KE, Bassetti MF, Glide-Hurst CK, Raldow AC, Yang Y, Portelance L, Padgett KR, Zaki B, Zhang R, Kim H, Henke LE, Price AT, Mancias JD, Williams CL, Ng J, Pennell R, Pfeffer MR, Levin D, Mueller AC, Mooney KE, Kelly P, Shah AP, Boldrini L, Placidi L, Fuss M, Chuong MD. A Multi-Institutional Phase 2 Trial of Ablative 5-Fraction Stereotactic Magnetic Resonance-Guided On-Table Adaptive Radiation Therapy for Borderline Resectable and Locally Advanced Pancreatic Cancer. Int J Radiat Oncol Biol Phys. 2023 Nov 15;117(4):799-808. doi: 10.1016/j.ijrobp.2023.05.023. Epub 2023 May 19.
PubMed 37210048
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Phase II Study of Stereotactic Magnetic Resonance Imaging (MRI) Guided On-table Adaptive Radiation Therapy (SMART) for Patients With Borderline or Inoperable Locally Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT03621644
- Acronym / sponsor ID
- VR C2T2 - SMART - LAPC/BRPC 1
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic Cancer, Radiation Therapy, SBRT
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 133 participants (estimated)
- Lead sponsor
- Viewray Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 3 Aug 2022 (actual)
- Study completion
- Jan 2027 (estimated)
- First posted
- 8 Aug 2018 (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.
High-dose magnetic resonance imaging (MRI) guided hypofractionated radiation therapy delivered using daily adaptive dose planning has been shown in a retrospective study to result in improved overall survival, relative to patients receiving lower radiation doses, in patients with locally advanced pancreatic cancer, without increasing the rate of serious gastrointestinal toxicity.
The goal of the proposed trial is to investigative in a controlled, prospective manner the robustness of this outcome, and to track quality of life over a 5-year trial period.
Detailed description
Prior stereotactic body radiotherapy (SBRT) experiences for treatment of locally advanced pancreatic cancer entailed either single-fraction or multi-fraction approaches delivering 33 Gray (Gy) in 5 fractions. Excellent tolerance and tumor control has been demonstrated, but median survival remained approximately 14 months. This highlights the strengths and limitations of SBRT to current radiation doses for pancreatic cancer. A prior Washington University institutional study and retrospective review has shown the safety of delivering 67.5 Gy in 15 fractions for inoperable pancreatic cancer using a strict 'isotoxicity' approach of limiting the gastrointestinal (GI) organs at risk (stomach, duodenum, small bowel and large bowel) to 45 Gy to 0.5 cm3 or less. This regimen resulted in no grade 3 or higher GI toxicities, and only one death in the 19 patients with a median follow-up of 15 months. This is significantly improved from prior experiences, where approximately 15 months represents the median survival for most studies of inoperable pancreatic cancer.
A recent retrospective analysis of 42 locally advanced pancreatic cancer patients treated by magnetic resonance imaging (MRI) guided radiation therapy at four institutions (University of California, Los Angeles, University of Wisconsin, Vrije Universiteit Medical Center (VUmc), Amsterdam, and Washington University, St. Louis) demonstrated that high-dose stereotactic body radiotherapy (SBRT) or hypofractionated radiation therapy delivered using daily ADAPTIVE dose planning on an MRI-guided radiotherapy system (MRIdian, ViewRay Inc.) has the potential to further improve overall survival. A control group of 19 patients treated to more conventional radiation doses without frequent dose adaptation showed a median survival of 14.8 months, while patients treated to high radiation doses (n=23, maximum biologically equivalent dose at alpha/beta = 10 Gy, or BED10 of > 90 Gy) under daily or almost daily adaptive re-planning had an estimated median survival of 27.8 months (p=0.005). Interestingly, increased radiation dose delivery using daily dose adaptation was correlated with less grade 3 toxicity (0% in the high dose group vs 15.8% in patients treated to lower radiation doses without dose adaptation).
The compelling data of this retrospective study prompted the development of this current prospective clinical trial designed to assess the primary objective of grade 3 or greater GI toxicity at 90 days for patients with borderline resectable or inoperable locally advanced pancreatic cancer treated with MRI-guided on-table adaptive radiation therapy and soft tissue tracking with radiation beam gating to 50 Gy in 5 fractions. Secondary objectives include assessment of (1) overall survival at 2 years, (2) distant progression free survival at 6 months, and (3) changes in patient-reported quality of life (QOL) from pre-treatment to 3 and 12 months post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ablative MRIdian SMART | Experimental | Radiation: Stereotactic MRI-guided On-table Adaptive Radiation TherapyRadiation: Stereotactic MRI-guided On-table Adaptive Radiation Therapy 50 Gy in 5 fractions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically or cytologically confirmed locally advanced adenocarcinoma of the pancreas that is considered unresectable or borderline resectable on institutional standardized criteria of unresectability or medical inoperability. Patients with and without regional adenopathy are eligible as long as lymph nodes are adjacent to primary tumor.
- Greater than or equal to 3 months of systemic chemotherapy
- At least 18 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
- Normal bone marrow and organ function as defined below:
Key exclusion criteria (8 listed)
- Distant metastatic disease as assessed by staging positron emission tomography / computed tomography (PET/CT) or CT of the chest and abdomen within 6 weeks of starting radiation therapy
- Carbohydrate antigen (CA19.9) > 500 U/ml.
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.
- Currently receiving any other investigational agents.
- Major surgery within 4 weeks prior to first day of treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic MRI-guided On-table Adaptive Radiation TherapyRadiation therapy will be delivered with an integrated magnetic resonance imaging (MRI)-guided radiotherapy delivery system (ViewRay MRIdian or MRIdian Linac). The prescribed dose will be 50 Gray (Gy) in 5 fractions. Stereotactic body radiotherapy (SBRT) fractions will be delivered at least twice per week, and with at least 18 hours between fractions. Each participant will be aligned in the treatment system with MRI image-guidance. On-table adaptive re-planning will be used when clinically indicated. In all patients, real-time MRI imaging will be used throughout treatment delivery to monitor the target location and control the radiation beam as necessary. | Radiation | Ablative MRIdian SMART |
Primary outcome
Gastrointestinal toxicity assessed using Common Terminology Criteria for Adverse Events (CTCAE) v5
Time frame: 90 days
Grade 3 or higher gastrointestinal toxicity assessed using Common Terminology Criteria for Adverse Events (CTCAE) v5 within 90 days of completion of radiation therapy
3 secondary outcomes
Overall survival
Time frame: 2 years
Distant progression-free survival
Time frame: 6 months
Patient-reported quality of life (QOL)
Time frame: 3 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2022.
- Background: PubMed 30932367Rudra S, Jiang N, Rosenberg SA, Olsen JR, Roach MC, Wan L, Portelance L, Mellon EA, Bruynzeel A, Lagerwaard F, Bassetti MF, Parikh PJ, Lee PP. Using adaptive magnetic resonance image-guided radiation therapy for treatment of inoperable pancreatic cancer. Cancer Med. 2019 May;8(5):2123-2132. doi: 10.1002/cam4.2100. Epub 2019 Apr 1.
- Derived from this study: PubMed 37210048Parikh PJ, Lee P, Low DA, Kim J, Mittauer KE, Bassetti MF, Glide-Hurst CK, Raldow AC, Yang Y, Portelance L, Padgett KR, Zaki B, Zhang R, Kim H, Henke LE, Price AT, Mancias JD, Williams CL, Ng J, Pennell R, Pfeffer MR, Levin D, Mueller AC, Mooney KE, Kelly P, Shah AP, Boldrini L, Placidi L, Fuss M, Chuong MD. A Multi-Institutional Phase 2 Trial of Ablative 5-Fraction Stereotactic Magnetic Resonance-Guided On-Table Adaptive Radiation Therapy for Borderline Resectable and Locally Advanced Pancreatic Cancer. Int J Radiat Oncol Biol Phys. 2023 Nov 15;117(4):799-808. doi: 10.1016/j.ijrobp.2023.05.023. Epub 2023 May 19.
- Parag Parikh, MD: Improving Pancreatic Cancer Survival by using MR Guided Adaptive RadiationLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Pancreatic Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer
Recruiting
Implementation of a Pain Management Plan in Major Open Abdominal Surgeries.
Abdomen Cancer, Pancreas Adenocarcinoma (MSI-H)
Active, not recruitingPhase 2
Pembrolizumab With Olaparib as Combined Therapy in Metastatic Pancreatic Cancer
Pancreatic Cancer
RecruitingPhase 2/3
Zanzalintinib Versus Everolimus in Participants With Locally Advanced or Metastatic Neuroendocrine Tumors
Pancreatic Neuroendocrine Tumor (pNET), Extra-Pancreatic Neuroendocrine Tumor (epNET)
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.
Parag J Parikh, MD principal investigator
Henry Ford Health System
Percy Lee, MD principal investigator
MD Anderson
Daniel Low, PhD principal investigator
University of California, Los Angeles
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic MRI-guided On-table Adaptive Radiation Therapy in people with Pancreatic Cancer, run by Viewray Inc. at 13 sites in 2 countries.
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 12 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: under way, not looking for participants, as of the sponsor's last update on 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Israel. 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?
Gastrointestinal toxicity assessed using Common Terminology Criteria for Adverse Events (CTCAE) v5 (time frame: 90 days). 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 NCT03621644, 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 14 Oct 2022.