SarcomaNCT02579980
Quantitative Imaging Biomarkers for Sarcoma
A study testing DCE and DWI MRI and Surgery in people with Sarcoma, run by Columbia University at 2 sites in United States.
Trial summary
Unless a cancer quickly gets smaller with radiation or chemotherapy, the investigators cannot tell if the treatment is working or not. In this research program, two techniques using magnetic resonance imaging (MRI) scanning will be tested in people who have sarcomas, which are rare cancers starting in muscle, tendons… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma
- What is being tested?
- DCE and DWI MRI and Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2015to Dec 2017
- Phase
- Interventional
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- New diagnosis of de novo sarcoma of all histologies (including soft tissue sarcoma, osteosarcoma, Ewing sarcoma, and chondrosarcoma) confirmed by biopsy
- Scheduled to be treated with surgical resection at the sarcoma or cancer center of participating sites
- Availability of the patient's medical information
- Provide written informed consent for the study
- Eighteen years of age or older
- Ability to remain motionless in MRI scanner for approximately 40 minutes
Who cannot join
- Patients with contra-indications for contrast enhanced MR exam, including:
- Cardiac pacemaker or pacemaker wiring in situ
- Cerebral clips or metal artificial cardiac valves
- Ossicle prosthesis
- Conditions that could produce a dangerous situation in the presence of a strong magnetic field: line metallic implants, shrapnel, inability to lie still, and conditions that can worsen inside confined spaces (severe claustrophobia, psychosis)
- Acute or chronic severe renal disease as determined by glomerular filtration rate (GFR) < 30 ml/min/1.73m2
- Pregnancy or breastfeeding
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Columbia University Medical Center
New York, New York, 10032
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, 84112
About this study
Official title: Development of Quantitative Imaging Biomarkers for Evaluating Sarcoma Patients
Unless a cancer quickly gets smaller with radiation or chemotherapy, the investigators cannot tell if the treatment is working or not. In this research program, two techniques using magnetic resonance imaging (MRI) scanning will be tested in people who have sarcomas, which are rare cancers starting in muscle, tendons, and bones. These particular MRI tests are called dynamic contrast enhanced MRI and diffusion weighted MRI. These MRI scans allow visualization of how sarcomas are different from the normal organs of the body. These MRI tests will tell us the location of sarcoma and its proximity to other structures, as well as correlation of imaging with pathological characteristics after surgery
Read the detailed description
Dynamic Contrast Enhanced MRI (DCE-MRI) and Diffusion Weighted MRI (DW-MRI) are imaging approaches that are being utilized in preclinical evaluation as well as clinical trials. DW-MRI is a technique for quantifying the increase in water diffusion caused by cellular necrosis or apoptosis in tumors within days of therapy. DCE-MRI is frequently used in preclinical and early clinical trial assessment of anti-angiogenic and vascular disrupting compounds, also within hours of therapeutic intervention. Evidence of drug efficacy and dose-dependent response has been demonstrated with certain angiogenesis inhibitors. It may also provide useful information for identifying early disease progression, independent of the treatment modality. While these approaches provide additional functional information, they have yet to be validated in sarcoma patients. This study seeks to develop a standardized protocol for performing DCE-MRI and DW-MRI and implement this in a clinical trial of patients with sarcomas who will have surgical resection as part of their standard care. This will allow the accuracy of in vivo MRI measurements to be directly compared to histology as ground truth. The study will also determine the reproducibility of these techniques using repeat baseline imaging as well as evaluate the quantitative changes in these parameters before and after therapy and correlate with histopathology. The collaboration between Columbia University and the University of Utah for this project will allow the existing quantitative MRI approaches to be expanded to a multi-center setting, and will establish a paradigm infrastructure for future expansion to larger scale multi-center therapeutic trials in sarcoma.
- Conditions
- Sarcoma
- Being tested
- DCE and DWI MRI, Surgery
- Keywords
- Dynamic Contrast Enhanced MRI, Diffusion Weighted MRI, Magnetic Resonance Imaging (MRI)
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DCE and DWI MRIProcedure or surgery
Dynamic Contrast Enhanced MRI (DCE-MRI) and Diffusion Weighted MRI (DW-MRI): DW-MRI is a technique for quantifying the increase in water diffusion caused by cellular necrosis or apoptosis in tumors within days of therapy. DCE-MRI is frequently used in preclinical and early clinical trial assessment of anti-angiogenic and vascular disrupting compounds, also within hours of therapeutic intervention.
SurgeryProcedure or surgery
Also called Tumor resection
Standard of care procedure for sarcoma patients
| Study group | Role | What they receive |
|---|---|---|
| DCE and DWI MRI group | Experimental | Patients will undergo a baseline MR exam at enrollment within 4 weeks prior to scheduled surgery, which will include DW-MRI and DCE-MRI prior to surgery and tumor tissue collection. Receives: Procedure: DCE and DWI MRI; Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation coefficient of Ktrans (DCE MR parameter) and Apparent Diffusion Coefficient (ADC) (DWI MR parameter) with microvessel density obtained from histopathology.
The primary endpoint of this study is to evaluate the correlation of the estimated in vivo Dynamic Contrast Enhanced and Diffusion weighted MRI parameters with ex vivo histopathologic measurements obtained from tumor tissue. Correlation coefficient (range: -1 to 1).
Measured: through study completion, an average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Lawrence Schwartz, Columbia University
- Investigators
- Lawrence H Schwartz, MD, Principal investigator, James Picker Professor and Chairman Department of Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02579980
- Sponsor's protocol ID
- AAAO9603
- Other IDs
- U54CA168512
- Status last verified
- Mar 2019
- First submitted
- 15 Oct 2015
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jacobs MA, Herskovits EH, Kim HS. Uterine fibroids: diffusion-weighted MR imaging for monitoring therapy with focused ultrasound surgery--preliminary study. Radiology. 2005 Jul;236(1):196-203. doi: 10.1148/radiol.2361040312.
PubMed 15987974Castillo M, Arbelaez A, Smith JK, Fisher LL. Diffusion-weighted MR imaging offers no advantage over routine noncontrast MR imaging in the detection of vertebral metastases. AJNR Am J Neuroradiol. 2000 May;21(5):948-53.
PubMed 10815675Chenevert TL, Meyer CR, Moffat BA, Rehemtulla A, Mukherji SK, Gebarski SS, Quint DJ, Robertson PL, Lawrence TS, Junck L, Taylor JM, Johnson TD, Dong Q, Muraszko KM, Brunberg JA, Ross BD. Diffusion MRI: a new strategy for assessment of cancer therapeutic efficacy. Mol Imaging. 2002 Oct;1(4):336-43. doi: 10.1162/15353500200221482.
PubMed 12926229Ei Khouli RH, Jacobs MA, Mezban SD, Huang P, Kamel IR, Macura KJ, Bluemke DA. Diffusion-weighted imaging improves the diagnostic accuracy of conventional 3.0-T breast MR imaging. Radiology. 2010 Jul;256(1):64-73. doi: 10.1148/radiol.10091367.
PubMed 20574085Herneth AM, Friedrich K, Weidekamm C, Schibany N, Krestan C, Czerny C, Kainberger F. Diffusion weighted imaging of bone marrow pathologies. Eur J Radiol. 2005 Jul;55(1):74-83. doi: 10.1016/j.ejrad.2005.03.031.
PubMed 15921871Jacobs MA, Ouwerkerk R, Kamel I, Bottomley PA, Bluemke DA, Kim HS. Proton, diffusion-weighted imaging, and sodium (23Na) MRI of uterine leiomyomata after MR-guided high-intensity focused ultrasound: a preliminary study. J Magn Reson Imaging. 2009 Mar;29(3):649-56. doi: 10.1002/jmri.21677.
PubMed 19243047Jin G, An N, Jacobs MA, Li K. The role of parallel diffusion-weighted imaging and apparent diffusion coefficient (ADC) map values for evaluating breast lesions: preliminary results. Acad Radiol. 2010 Apr;17(4):456-63. doi: 10.1016/j.acra.2009.12.004.
PubMed 20207316Mintorovitch J, Moseley ME, Chileuitt L, Shimizu H, Cohen Y, Weinstein PR. Comparison of diffusion- and T2-weighted MRI for the early detection of cerebral ischemia and reperfusion in rats. Magn Reson Med. 1991 Mar;18(1):39-50. doi: 10.1002/mrm.1910180106.
PubMed 2062240Moseley ME, Kucharczyk J, Mintorovitch J, Cohen Y, Kurhanewicz J, Derugin N, Asgari H, Norman D. Diffusion-weighted MR imaging of acute stroke: correlation with T2-weighted and magnetic susceptibility-enhanced MR imaging in cats. AJNR Am J Neuroradiol. 1990 May;11(3):423-9.
PubMed 2161612Babsky AM, Topper S, Zhang H, Gao Y, James JR, Hekmatyar SK, Bansal N. Evaluation of extra- and intracellular apparent diffusion coefficient of sodium in rat skeletal muscle: effects of prolonged ischemia. Magn Reson Med. 2008 Mar;59(3):485-91. doi: 10.1002/mrm.21568.
PubMed 18306401Le Bihan D, Breton E, Lallemand D, Aubin ML, Vignaud J, Laval-Jeantet M. Separation of diffusion and perfusion in intravoxel incoherent motion MR imaging. Radiology. 1988 Aug;168(2):497-505. doi: 10.1148/radiology.168.2.3393671.
PubMed 3393671Le Bihan D, Breton E, Lallemand D, Grenier P, Cabanis E, Laval-Jeantet M. MR imaging of intravoxel incoherent motions: application to diffusion and perfusion in neurologic disorders. Radiology. 1986 Nov;161(2):401-7. doi: 10.1148/radiology.161.2.3763909.
PubMed 3763909Szafer A, Zhong J, Gore JC. Theoretical model for water diffusion in tissues. Magn Reson Med. 1995 May;33(5):697-712. doi: 10.1002/mrm.1910330516.
PubMed 7596275Knight RA, Ordidge RJ, Helpern JA, Chopp M, Rodolosi LC, Peck D. Temporal evolution of ischemic damage in rat brain measured by proton nuclear magnetic resonance imaging. Stroke. 1991 Jun;22(6):802-8. doi: 10.1161/01.str.22.6.802.
PubMed 2057981Jacobs MA, Ouwerkerk R, Wolff AC, Stearns V, Bottomley PA, Barker PB, Argani P, Khouri N, Davidson NE, Bhujwalla ZM, Bluemke DA. Multiparametric and multinuclear magnetic resonance imaging of human breast cancer: current applications. Technol Cancer Res Treat. 2004 Dec;3(6):543-50. doi: 10.1177/153303460400300603.
PubMed 15560711
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Quantitative Imaging Biomarkers for Evaluating Sarcoma Patients
- ClinicalTrials.gov ID
- NCT02579980
- Acronym / sponsor ID
- AAAO9603
- Conditions
- Sarcoma
- Keywords
- Dynamic Contrast Enhanced MRI, Diffusion Weighted MRI, Magnetic Resonance Imaging (MRI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 20 Oct 2015 (estimated)
- 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.
Unless a cancer quickly gets smaller with radiation or chemotherapy, the investigators cannot tell if the treatment is working or not. In this research program, two techniques using magnetic resonance imaging (MRI) scanning will be tested in people who have sarcomas, which are rare cancers starting in muscle, tendons, and bones. These particular MRI tests are called dynamic contrast enhanced MRI and diffusion weighted MRI. These MRI scans allow visualization of how sarcomas are different from the normal organs of the body. These MRI tests will tell us the location of sarcoma and its proximity to other structures, as well as correlation of imaging with pathological characteristics after surgery
Detailed description
Dynamic Contrast Enhanced MRI (DCE-MRI) and Diffusion Weighted MRI (DW-MRI) are imaging approaches that are being utilized in preclinical evaluation as well as clinical trials. DW-MRI is a technique for quantifying the increase in water diffusion caused by cellular necrosis or apoptosis in tumors within days of therapy. DCE-MRI is frequently used in preclinical and early clinical trial assessment of anti-angiogenic and vascular disrupting compounds, also within hours of therapeutic intervention. Evidence of drug efficacy and dose-dependent response has been demonstrated with certain angiogenesis inhibitors. It may also provide useful information for identifying early disease progression, independent of the treatment modality. While these approaches provide additional functional information, they have yet to be validated in sarcoma patients. This study seeks to develop a standardized protocol for performing DCE-MRI and DW-MRI and implement this in a clinical trial of patients with sarcomas who will have surgical resection as part of their standard care. This will allow the accuracy of in vivo MRI measurements to be directly compared to histology as ground truth. The study will also determine the reproducibility of these techniques using repeat baseline imaging as well as evaluate the quantitative changes in these parameters before and after therapy and correlate with histopathology. The collaboration between Columbia University and the University of Utah for this project will allow the existing quantitative MRI approaches to be expanded to a multi-center setting, and will establish a paradigm infrastructure for future expansion to larger scale multi-center therapeutic trials in sarcoma.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DCE and DWI MRI group | Experimental | Procedure: DCE and DWI MRI, Procedure: SurgeryPatients will undergo a baseline MR exam at enrollment within 4 weeks prior to scheduled surgery, which will include DW-MRI and DCE-MRI prior to surgery and tumor tissue collection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- New diagnosis of de novo sarcoma of all histologies (including soft tissue sarcoma, osteosarcoma, Ewing sarcoma, and chondrosarcoma) confirmed by biopsy
- Scheduled to be treated with surgical resection at the sarcoma or cancer center of participating sites
- Availability of the patient's medical information
- Provide written informed consent for the study
- Eighteen years of age or older
Key exclusion criteria (7 listed)
- Patients with contra-indications for contrast enhanced MR exam, including:
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 |
|---|---|---|
| DCE and DWI MRIDynamic Contrast Enhanced MRI (DCE-MRI) and Diffusion Weighted MRI (DW-MRI): DW-MRI is a technique for quantifying the increase in water diffusion caused by cellular necrosis or apoptosis in tumors within days of therapy. DCE-MRI is frequently used in preclinical and early clinical trial assessment of anti-angiogenic and vascular disrupting compounds, also within hours of therapeutic intervention. | Procedure or surgery | DCE and DWI MRI group |
| SurgeryAlso: Tumor resectionStandard of care procedure for sarcoma patients | Procedure or surgery | DCE and DWI MRI group |
Primary outcome
Correlation coefficient of Ktrans (DCE MR parameter) and Apparent Diffusion Coefficient (ADC) (DWI MR parameter) with microvessel density obtained from histopathology.
Time frame: through study completion, an average of 4 weeks
The primary endpoint of this study is to evaluate the correlation of the estimated in vivo Dynamic Contrast Enhanced and Diffusion weighted MRI parameters with ex vivo histopathologic measurements obtained from tumor tissue. Correlation coefficient (range: -1 to 1).
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 26 Mar 2019.
- Background: PubMed 15987974Jacobs MA, Herskovits EH, Kim HS. Uterine fibroids: diffusion-weighted MR imaging for monitoring therapy with focused ultrasound surgery--preliminary study. Radiology. 2005 Jul;236(1):196-203. doi: 10.1148/radiol.2361040312.
- Background: PubMed 10815675Castillo M, Arbelaez A, Smith JK, Fisher LL. Diffusion-weighted MR imaging offers no advantage over routine noncontrast MR imaging in the detection of vertebral metastases. AJNR Am J Neuroradiol. 2000 May;21(5):948-53.
- Background: PubMed 12926229Chenevert TL, Meyer CR, Moffat BA, Rehemtulla A, Mukherji SK, Gebarski SS, Quint DJ, Robertson PL, Lawrence TS, Junck L, Taylor JM, Johnson TD, Dong Q, Muraszko KM, Brunberg JA, Ross BD. Diffusion MRI: a new strategy for assessment of cancer therapeutic efficacy. Mol Imaging. 2002 Oct;1(4):336-43. doi: 10.1162/15353500200221482.
- Background: PubMed 20574085Ei Khouli RH, Jacobs MA, Mezban SD, Huang P, Kamel IR, Macura KJ, Bluemke DA. Diffusion-weighted imaging improves the diagnostic accuracy of conventional 3.0-T breast MR imaging. Radiology. 2010 Jul;256(1):64-73. doi: 10.1148/radiol.10091367.
- Background: PubMed 15921871Herneth AM, Friedrich K, Weidekamm C, Schibany N, Krestan C, Czerny C, Kainberger F. Diffusion weighted imaging of bone marrow pathologies. Eur J Radiol. 2005 Jul;55(1):74-83. doi: 10.1016/j.ejrad.2005.03.031.
- Background: PubMed 19243047Jacobs MA, Ouwerkerk R, Kamel I, Bottomley PA, Bluemke DA, Kim HS. Proton, diffusion-weighted imaging, and sodium (23Na) MRI of uterine leiomyomata after MR-guided high-intensity focused ultrasound: a preliminary study. J Magn Reson Imaging. 2009 Mar;29(3):649-56. doi: 10.1002/jmri.21677.
- Background: PubMed 20207316Jin G, An N, Jacobs MA, Li K. The role of parallel diffusion-weighted imaging and apparent diffusion coefficient (ADC) map values for evaluating breast lesions: preliminary results. Acad Radiol. 2010 Apr;17(4):456-63. doi: 10.1016/j.acra.2009.12.004.
- Background: PubMed 2062240Mintorovitch J, Moseley ME, Chileuitt L, Shimizu H, Cohen Y, Weinstein PR. Comparison of diffusion- and T2-weighted MRI for the early detection of cerebral ischemia and reperfusion in rats. Magn Reson Med. 1991 Mar;18(1):39-50. doi: 10.1002/mrm.1910180106.
- Background: PubMed 2161612Moseley ME, Kucharczyk J, Mintorovitch J, Cohen Y, Kurhanewicz J, Derugin N, Asgari H, Norman D. Diffusion-weighted MR imaging of acute stroke: correlation with T2-weighted and magnetic susceptibility-enhanced MR imaging in cats. AJNR Am J Neuroradiol. 1990 May;11(3):423-9.
- Background: PubMed 18306401Babsky AM, Topper S, Zhang H, Gao Y, James JR, Hekmatyar SK, Bansal N. Evaluation of extra- and intracellular apparent diffusion coefficient of sodium in rat skeletal muscle: effects of prolonged ischemia. Magn Reson Med. 2008 Mar;59(3):485-91. doi: 10.1002/mrm.21568.
- Background: PubMed 3393671Le Bihan D, Breton E, Lallemand D, Aubin ML, Vignaud J, Laval-Jeantet M. Separation of diffusion and perfusion in intravoxel incoherent motion MR imaging. Radiology. 1988 Aug;168(2):497-505. doi: 10.1148/radiology.168.2.3393671.
- Background: PubMed 3763909Le Bihan D, Breton E, Lallemand D, Grenier P, Cabanis E, Laval-Jeantet M. MR imaging of intravoxel incoherent motions: application to diffusion and perfusion in neurologic disorders. Radiology. 1986 Nov;161(2):401-7. doi: 10.1148/radiology.161.2.3763909.
- DCE-MRI Technical Committee. DCE-MRI Quantification Profile, Quantitative Imaging Biomarkers Alliance (QIBA). Version 1.0. Publicly Reviewed Version. QIBA.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Lawrence H Schwartz, MD principal investigator
James Picker Professor and Chairman Department of Radiology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DCE and DWI MRI and Surgery in people with Sarcoma, run by Columbia University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 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 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Correlation coefficient of Ktrans (DCE MR parameter) and Apparent Diffusion Coefficient (ADC) (DWI MR parameter) with microvessel density obtained from histopathology. (time frame: through study completion, an average of 4 weeks). 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 NCT02579980, which also lists 38 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 26 Mar 2019.