Rectal CancerLimerickNCT05215535
Liver Magnetic Resonance Imaging Before Treatment for Rectal Cancer. A Randomised Controlled Trial.
A study testing Abbreviated MRI of the liver/abdomen and Combined single venous and 3 min equilibrium phase CT of the abdomen/liver in people with Rectal Cancer, run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
This multicentre randomized controlled trial aims to investigate whether an abbreviated MRI is comparable to a combined single venous phase CT with an additional 3 min equilibrium phase of the liver, in the pretreatment radiological workup in patients with rectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Abbreviated MRI of the liver/abdomen and Combined single venous and 3 min equilibrium phase CT of the abdomen/liver
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteSweden
- Study dates
- 12 Apr 2022to Dec 2029
- 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
- Adults >18 years of age
- Endoscopically or clinically diagnosed with (suspected) rectal cancer and considered for further radiological investigation
- Are able to understand trial information and provide oral and written consent
Who cannot join
- Patients unable to undergo MRI (causes may include claustrophobia, presence of pacemaker or certain metal components in their body).
- Patients diagnosed with benign disease of the rectum or squamous cell carcinoma
- Patients diagnosed with recurrent rectal cancer
- Patients unable to understand the trial information
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Sahlgrenska University Hospital/Östra
Gothenburg
Jennifer Park, MD, PhD, jennifer.park@vgregion.se
About this study
Official title: Limerick - Liver Magnetic Resonance Imaging Before Treatment for Rectal Cancer. A Randomised Controlled Trial.
This multicentre randomized controlled trial aims to investigate whether an abbreviated MRI is comparable to a combined single venous phase CT with an additional 3 min equilibrium phase of the liver, in the pretreatment radiological workup in patients with rectal cancer.
Read the detailed description
The incidence of rectal cancer in the European Union is approximately 125 000 per year, constituting a third of the total colorectal cancer incidence(1). In Sweden approximately 2000 individuals are diagnosed with rectal cancer each year. Evaluation of patients and possible treatment strategies (including neo-adjuvant chemo/radiotherapy, choice of surgical technique and adjuvant chemotherapy) are based on tumor specific characteristics together with patient factors such as general condition and comorbidity. These characteristics include tumor, lymph node and metastasis classification (cTNM), height of tumor (distance from anal verge), engagement of circumferential margin or mesorectal fascia, signs of extramural invasion and the presence of distant metastases. Clinical examination and endoscopy together with magnetic resonance imaging (MRI) of the pelvic region are essential in the local staging process, where MRI provides the most accurate radiological assessment, especially for rectal tumors in stage T3 and T4. The recommended methods regarding evaluation of metastases (M stage) include contrast enhanced computed tomography (CT) or MRI of the liver/abdomen, CT of the thorax, and in selected cases positron emission tomography (PET)- CT, if extensive extramural vascular invasion is present.
Previous studies have investigated the efficiency of MRI compared to other radiological methods and found that MRI of the liver is superior to contrast enhanced CT, in terms of specificity and sensitivity for diagnosis of liver metastasis (both per patient and per lesion).
Even though MRI has been recommended as the first line modality for evaluating colorectal cancer liver metastases in patients who have not previously undergone therapy the Swedish national guidelines, as well as the European Society for Medical Oncology (ESMO), include recommendations of single venous phased contrast enhanced CT of the liver/abdomen in the pre-treatment radiological workup. Progress within diagnostics has led to development of CT examination with an additional 3 min equilibrium phase of the liver that may be added to the single venous phase in order to increase the sensitivity and specificity of the diagnosis of liver metastases. However, this has not yet been included in guidelines nor implemented on a national basis in the pre-treatment radiological workup in patients with colorectal cancer.
Objective The primary objective of the present study is to compare percentage of patients requiring further radiological examinations after index examination (due to inconclusive results) between patients randomized to an abbreviated MRI liver protocol and patients randomized to a combined single venous phase CT with an additional 3 min equilibrium phase of the liver. A secondary aim is to compare time to treatment initiation, survival and development of liver metatstases between patients randomized to either an abbreviated MRI or a combined single-venous phase CT with an additional 3 min equilibrium phase of the liver.
The study is a multicentre randomized controlled trial where the hypothesis is that there is no clinical difference between the two groups, and the study is designed as a non inferiority trial.
- Conditions
- Rectal Cancer
- Being tested
- Abbreviated MRI of the liver/abdomen, Combined single venous and 3 min equilibrium phase CT of the abdomen/liver
- Keywords
- rectal cancer, radiological examination liver
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abbreviated MRI of the liver/abdomenRadiation
The MRI examinations of the liver/abdomen will be performed at the same time as the pelvic MRI. A 1,5 T scanner will be used together with a dedicated torso/abdominal coil. An abbreviated MRI liver protocol includes 3 different sequences as follows:
- Axial T2-weighted respiratory triggered sequence with 5 mm slice thickness.
- Axial diffusion weighted spin echo respiratory triggered sequence with fatsat with b-factors 50/800 s/mm2 and ADC calculation maps, 5 mm slice thickness
- An axial breath-hold 3D T1-weighted gradient echo with fatsat with 4 mm slice thickness, gap 2 mm, contrast enhanced venous phase and in a 3 min equilibrium phase, using regular i.v bolus injection of gadolinium contrast medium with standard clinical dose.
Combined single venous and 3 min equilibrium phase CT of the abdomen/liverRadiation
The CT examination of the liver will be performed as a combined examination in a single venous phase starting with the thoracic region directly followed by the abdomen down to the pelvis. An additional 3 min equilibrium phase of the liver only will end the examination. Regular iodinated low-osmolar non-ionic contrast media will be used of 350 mg I/ml using a power injector, 2-4 ml/s, 100-150 ml dependent on patient weight and kidney function. Reconstructed images in axial, coronal and sagittal plane will be performed.
| Study group | Role | What they receive |
|---|---|---|
| MRI group | Experimental | An abbreviated MRI of the liver/abdomen Receives: Radiation: Abbreviated MRI of the liver/abdomen |
| CT group | Active comparator | A combined single venous and 3 min equilibrium phase CT of the abdomen/liver Receives: Radiation: Combined single venous and 3 min equilibrium phase CT of the abdomen/liver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for supplementary radiologic liver examination
Number of patients in need for supplementary radiologic liver examination/s before treatment decision, after index examination (CT or MRI) of the abdominal organs, due to inconclusive results.
Measured: 3 months
Cost effectiveness
Costs related to all index radiological examinations will be included. Costs will be collected from national sources such as the Swedish association of local authorities and regions (SKR - Sveriges kommuner och regioner) whenever possible and alternatively from Sahlgrenska university hospital cost-per-patient files. Possibly a more complex model will be relevant depending on outcome, where total health care costs are compared between the two radiological work-up routines. Such an analysis will take survival into account.
Measured: 12 months
Secondary outcomes (4)
Time to start of treatment
Time from index radiological workup to start of treatment
Measured: 12 months
Recurrence of rectal cancer
Number of patients with recurrence of rectal cancer (local or metastatic disease)
Measured: 12 months
Liver metastasis
Number of patients diagnosed with liver metastasis
Measured: 36 months
Survival
Overall survival
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start12 Apr 2022
- Primary completionDec 2027 (estimated)
- Study completionDec 2029 (estimated)
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 Rectal CancerStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Consenting patients with newly diagnosed rectal cancer who fulfil the inclusion criteria and no exclusion criteria will be randomized into two groups with regard to radiological investigation of the liver; Intervention: An abbreviated MRI of the liver/abdomen Control: A combined single venous and 3 min equilibrium phase CT of the abdomen/liver Randomization will be conducted in blocks of 6, and stratified for sex and hospital.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jennifer Park, MD, PhD, Principal investigator, Sahlgrenska University Hospital, Sahlgrenska Academy, Gothenburg Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05215535
- Sponsor's protocol ID
- Limerick
- Acronym
- Limerick
- Status last verified
- May 2024
- First submitted
- 15 Dec 2021
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Van Cutsem E, Cervantes A, Adam R, Sobrero A, Van Krieken JH, Aderka D, Aranda Aguilar E, Bardelli A, Benson A, Bodoky G, Ciardiello F, D'Hoore A, Diaz-Rubio E, Douillard JY, Ducreux M, Falcone A, Grothey A, Gruenberger T, Haustermans K, Heinemann V, Hoff P, Kohne CH, Labianca R, Laurent-Puig P, Ma B, Maughan T, Muro K, Normanno N, Osterlund P, Oyen WJ, Papamichael D, Pentheroudakis G, Pfeiffer P, Price TJ, Punt C, Ricke J, Roth A, Salazar R, Scheithauer W, Schmoll HJ, Tabernero J, Taieb J, Tejpar S, Wasan H, Yoshino T, Zaanan A, Arnold D. ESMO consensus guidelines for the management of patients with metastatic colorectal cancer. Ann Oncol. 2016 Aug;27(8):1386-422. doi: 10.1093/annonc/mdw235. Epub 2016 Jul 5.
PubMed 27380959Achiam MP, Logager VB, Skjoldbye B, Moller JM, Lorenzen T, Rasmussen VL, Thomsen HS, Mollerup TH, Okholm C, Rosenberg J. Preoperative CT versus diffusion weighted magnetic resonance imaging of the liver in patients with rectal cancer; a prospective randomized trial. PeerJ. 2016 Jan 14;4:e1532. doi: 10.7717/peerj.1532. eCollection 2016.
PubMed 26793420Niekel MC, Bipat S, Stoker J. Diagnostic imaging of colorectal liver metastases with CT, MR imaging, FDG PET, and/or FDG PET/CT: a meta-analysis of prospective studies including patients who have not previously undergone treatment. Radiology. 2010 Dec;257(3):674-84. doi: 10.1148/radiol.10100729. Epub 2010 Sep 9.
PubMed 20829538Ferlay J, Steliarova-Foucher E, Lortet-Tieulent J, Rosso S, Coebergh JW, Comber H, Forman D, Bray F. Cancer incidence and mortality patterns in Europe: estimates for 40 countries in 2012. Eur J Cancer. 2013 Apr;49(6):1374-403. doi: 10.1016/j.ejca.2012.12.027. Epub 2013 Feb 26.
PubMed 23485231
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Limerick - Liver Magnetic Resonance Imaging Before Treatment for Rectal Cancer. A Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT05215535
- Acronym / sponsor ID
- Limerick / Limerick
- Conditions
- Rectal Cancer
- Keywords
- rectal cancer, radiological examination liver
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 12 Apr 2022 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 31 Jan 2022 (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 multicentre randomized controlled trial aims to investigate whether an abbreviated MRI is comparable to a combined single venous phase CT with an additional 3 min equilibrium phase of the liver, in the pretreatment radiological workup in patients with rectal cancer.
Detailed description
The incidence of rectal cancer in the European Union is approximately 125 000 per year, constituting a third of the total colorectal cancer incidence(1). In Sweden approximately 2000 individuals are diagnosed with rectal cancer each year. Evaluation of patients and possible treatment strategies (including neo-adjuvant chemo/radiotherapy, choice of surgical technique and adjuvant chemotherapy) are based on tumor specific characteristics together with patient factors such as general condition and comorbidity. These characteristics include tumor, lymph node and metastasis classification (cTNM), height of tumor (distance from anal verge), engagement of circumferential margin or mesorectal fascia, signs of extramural invasion and the presence of distant metastases. Clinical examination and endoscopy together with magnetic resonance imaging (MRI) of the pelvic region are essential in the local staging process, where MRI provides the most accurate radiological assessment, especially for rectal tumors in stage T3 and T4. The recommended methods regarding evaluation of metastases (M stage) include contrast enhanced computed tomography (CT) or MRI of the liver/abdomen, CT of the thorax, and in selected cases positron emission tomography (PET)- CT, if extensive extramural vascular invasion is present.
Previous studies have investigated the efficiency of MRI compared to other radiological methods and found that MRI of the liver is superior to contrast enhanced CT, in terms of specificity and sensitivity for diagnosis of liver metastasis (both per patient and per lesion).
Even though MRI has been recommended as the first line modality for evaluating colorectal cancer liver metastases in patients who have not previously undergone therapy the Swedish national guidelines, as well as the European Society for Medical Oncology (ESMO), include recommendations of single venous phased contrast enhanced CT of the liver/abdomen in the pre-treatment radiological workup. Progress within diagnostics has led to development of CT examination with an additional 3 min equilibrium phase of the liver that may be added to the single venous phase in order to increase the sensitivity and specificity of the diagnosis of liver metastases. However, this has not yet been included in guidelines nor implemented on a national basis in the pre-treatment radiological workup in patients with colorectal cancer.
Objective The primary objective of the present study is to compare percentage of patients requiring further radiological examinations after index examination (due to inconclusive results) between patients randomized to an abbreviated MRI liver protocol and patients randomized to a combined single venous phase CT with an additional 3 min equilibrium phase of the liver. A secondary aim is to compare time to treatment initiation, survival and development of liver metatstases between patients randomized to either an abbreviated MRI or a combined single-venous phase CT with an additional 3 min equilibrium phase of the liver.
The study is a multicentre randomized controlled trial where the hypothesis is that there is no clinical difference between the two groups, and the study is designed as a non inferiority trial.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Consenting patients with newly diagnosed rectal cancer who fulfil the inclusion criteria and no exclusion criteria will be randomized into two groups with regard to radiological investigation of the liver; Intervention: An abbreviated MRI of the liver/abdomen Control: A combined single venous and 3 min equilibrium phase CT of the abdomen/liver Randomization will be conducted in blocks of 6, and stratified for sex and hospital.
| Arm | Type | Receives |
|---|---|---|
| MRI group | Experimental | Radiation: Abbreviated MRI of the liver/abdomenAn abbreviated MRI of the liver/abdomen |
| CT group | Active comparator | Radiation: Combined single venous and 3 min equilibrium phase CT of the abdomen/liverA combined single venous and 3 min equilibrium phase CT of the abdomen/liver |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults >18 years of age
- Endoscopically or clinically diagnosed with (suspected) rectal cancer and considered for further radiological investigation
- Are able to understand trial information and provide oral and written consent
Key exclusion criteria (4 listed)
- Patients unable to undergo MRI (causes may include claustrophobia, presence of pacemaker or certain metal components in their body).
- Patients diagnosed with benign disease of the rectum or squamous cell carcinoma
- Patients diagnosed with recurrent rectal cancer
- Patients unable to understand the trial information
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 |
|---|---|---|
| Abbreviated MRI of the liver/abdomenThe MRI examinations of the liver/abdomen will be performed at the same time as the pelvic MRI. A 1,5 T scanner will be used together with a dedicated torso/abdominal coil. An abbreviated MRI liver protocol includes 3 different sequences as follows: 1. Axial T2-weighted respiratory triggered sequence with 5 mm slice thickness. 2. Axial diffusion weighted spin echo respiratory triggered sequence with fatsat with b-factors 50/800 s/mm2 and ADC calculation maps, 5 mm slice thickness 3. An axial breath-hold 3D T1-weighted gradient echo with fatsat with 4 mm slice thickness, gap 2 mm, contrast enhanced venous phase and in a 3 min equilibrium phase, using regular i.v bolus injection of gadolinium contrast medium with standard clinical dose. | Radiation | MRI group |
| Combined single venous and 3 min equilibrium phase CT of the abdomen/liverThe CT examination of the liver will be performed as a combined examination in a single venous phase starting with the thoracic region directly followed by the abdomen down to the pelvis. An additional 3 min equilibrium phase of the liver only will end the examination. Regular iodinated low-osmolar non-ionic contrast media will be used of 350 mg I/ml using a power injector, 2-4 ml/s, 100-150 ml dependent on patient weight and kidney function. Reconstructed images in axial, coronal and sagittal plane will be performed. | Radiation | CT group |
Primary outcome
Need for supplementary radiologic liver examination
Time frame: 3 months
Number of patients in need for supplementary radiologic liver examination/s before treatment decision, after index examination (CT or MRI) of the abdominal organs, due to inconclusive results.
Cost effectiveness
Time frame: 12 months
Costs related to all index radiological examinations will be included. Costs will be collected from national sources such as the Swedish association of local authorities and regions (SKR - Sveriges kommuner och regioner) whenever possible and alternatively from Sahlgrenska university hospital cost-per-patient files. Possibly a more complex model will be relevant depending on outcome, where total health care costs are compared between the two radiological work-up routines. Such an analysis will take survival into account.
4 secondary outcomes
Time to start of treatment
Time frame: 12 months
Recurrence of rectal cancer
Time frame: 12 months
Liver metastasis
Time frame: 36 months
Survival
Time frame: 36 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 19 Aug 2024.
- Background: PubMed 27380959Van Cutsem E, Cervantes A, Adam R, Sobrero A, Van Krieken JH, Aderka D, Aranda Aguilar E, Bardelli A, Benson A, Bodoky G, Ciardiello F, D'Hoore A, Diaz-Rubio E, Douillard JY, Ducreux M, Falcone A, Grothey A, Gruenberger T, Haustermans K, Heinemann V, Hoff P, Kohne CH, Labianca R, Laurent-Puig P, Ma B, Maughan T, Muro K, Normanno N, Osterlund P, Oyen WJ, Papamichael D, Pentheroudakis G, Pfeiffer P, Price TJ, Punt C, Ricke J, Roth A, Salazar R, Scheithauer W, Schmoll HJ, Tabernero J, Taieb J, Tejpar S, Wasan H, Yoshino T, Zaanan A, Arnold D. ESMO consensus guidelines for the management of patients with metastatic colorectal cancer. Ann Oncol. 2016 Aug;27(8):1386-422. doi: 10.1093/annonc/mdw235. Epub 2016 Jul 5.
- Background: PubMed 26793420Achiam MP, Logager VB, Skjoldbye B, Moller JM, Lorenzen T, Rasmussen VL, Thomsen HS, Mollerup TH, Okholm C, Rosenberg J. Preoperative CT versus diffusion weighted magnetic resonance imaging of the liver in patients with rectal cancer; a prospective randomized trial. PeerJ. 2016 Jan 14;4:e1532. doi: 10.7717/peerj.1532. eCollection 2016.
- Background: PubMed 20829538Niekel MC, Bipat S, Stoker J. Diagnostic imaging of colorectal liver metastases with CT, MR imaging, FDG PET, and/or FDG PET/CT: a meta-analysis of prospective studies including patients who have not previously undergone treatment. Radiology. 2010 Dec;257(3):674-84. doi: 10.1148/radiol.10100729. Epub 2010 Sep 9.
- Background: PubMed 23485231Ferlay J, Steliarova-Foucher E, Lortet-Tieulent J, Rosso S, Coebergh JW, Comber H, Forman D, Bray F. Cancer incidence and mortality patterns in Europe: estimates for 40 countries in 2012. Eur J Cancer. 2013 Apr;49(6):1374-403. doi: 10.1016/j.ejca.2012.12.027. Epub 2013 Feb 26.
- National Cancer Care Guidelines for Colorectal Cancer \[National Cancer Care Guidelines\].Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Rectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal 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.
Jennifer Park, MD, PhD principal investigator
Sahlgrenska University Hospital, Sahlgrenska Academy, Gothenburg Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abbreviated MRI of the liver/abdomen and Combined single venous and 3 min equilibrium phase CT of the abdomen/liver in people with Rectal Cancer, run by Vastra Gotaland Region at 1 site in Sweden.
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 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2024. 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 Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Park, MD, PhD (+46-31-3436780, jennifer.park@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Need for supplementary radiologic liver examination (time frame: 3 months). The study lists 2 primary outcomes in all. 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 NCT05215535, 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 19 Aug 2024.