HepatoblastomaNCT04315883
Yttrium-90 (TARE-Y90) in Children, Adolescents, and Young Adults With Liver Tumors
An observational study of Hepatoblastoma and Hepatocellular Carcinoma, run by Nemours Children's Clinic at 2 sites in United States.
Trial summary
This study will be performed to evaluate the Clinical Outcomes and Quality of Life after Transarterial Radioembolization with Yttrium-90 (TARE-Y90) in Children, Adolescents, and Young Adults with Liver Tumors. The treatment and techniques used here are well established in adults. Read more about this study
- Who is it for?
- Ages 0 to 21 years
- Conditions the study is for
- Hepatoblastoma, Hepatocellular Carcinoma, Rhabdoid Tumor of Liver
- What is being tested?
- Quality of Life Assessment and Transarterial Radioembolization
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 3 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Feb 2021to 28 Mar 2024
- 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 0 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric and Young adult patients with liver tumors
Who may be able to join
- Boys and girls age < 21 years of age
- History of liver tumor
- Meet criteria for treatment with TARE-Y90
Who cannot join
- • Inability to complete required study procedures.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Nemours Children's Specialty Care
Jacksonville, Florida, 32207
Nemours-AI duPont Hospital for Children
Wilmington, Delaware, 19803
About this study
Official title: Clinical Outcomes and Quality of Life After Transarterial Radioembolization With Yttrium-90 (TARE-Y90) in Children, Adolescents, and Young Adults With Liver Tumors
This study will be performed to evaluate the Clinical Outcomes and Quality of Life after Transarterial Radioembolization with Yttrium-90 (TARE-Y90) in Children, Adolescents, and Young Adults with Liver Tumors. The treatment and techniques used here are well established in adults.
The purpose of this study is to evaluate:
- the response to treatment and clinical outcomes of treatment with TARE Y-90 as part of standard therapy and
- to assess the change in the patient's quality of life before, during and after treatment with TARE-Y90
Read the detailed description
- Referral to Nemours Liver Tumor Program is made by the primary team (oncologist/surgeon).
- Phone discussion between the Nemours Liver Tumor Program Team will occur with the referring team about the patient.
- Phone call between the Nemours Liver Tumor Program Team and the family will occur prior to any visit to discuss the potential plan of care and the basics of the TARE-Y90 procedure and the Quality of Life surveys.
Review of medical records provided by referring institution will be done by the Nemours Liver Tumor Program Team including:
History, Scans-actual imaging required, Path report-slide submission required, Roadmaps, Labs, Other pertinent medical history and records
-Visit to Nemours/AI DuPont Children's Hospital for initial consultation will be arranged by the Nemours Liver Tumor Program Team.
The patient and family will meet with the team including:
Liver transplant surgeon (Dr Dunn), Interventional Radiologist (Dr Aguado), Social worker, Child life specialist, Pediatric oncologist (Dr Gresh - on site, Dr Katzenstein by telemedicine)
- Attempt will be made to schedule the pre-planning angiogram as part of initial visit (2nd day of visit). The angiogram requires the following 3-4 hours (mapping of blood vessels in and around tumor - determines whether patient can receive Y90, Angiogram is done with the patient sedated and having been after midnight the night before, The patient is expected to be discharged on the same day of the angiogram- no admit is planned but occasionally the patient may need overnight observation to occur due to age of the patient or the length of the procedure.
- Return to home.
- Potential additional single cycle of chemotherapy may be given prior to return to Nemours for Y90.
All further Chemotherapy Care is coordinated with Nemours Liver Tumor oncologists
-A 2nd visit to AIDHC will occur for TARE-Y90 treatment: The procedure lasts about 2-3 hours. There is no planned admit but possible if any problems occur.
- 2 weeks post procedure a phone call follow-up after treatment will occur with the Nemours team
- 2 weeks post procedure the patient may resume chemotherapy when cleared by the Nemours team
- 4-6 weeks post Y90 treatment - a repeat CT/MRI will be done as well as lab tests.
- If possible, the CT/MRI to be done at AIDHC/Nemours but can be done locally if travel barriers exist.
- If the tumor is now resectable, planning will be made for resection at AIDHC/Nemours.
- Evaluation and change of HRQOL survey responses will be performed at baseline (time of treatment) and 1, 6, 12 months and 5 years post-treatment. These surveys will be done by phone, mail or email. Responses will be captured and entered into a REDCAP database
- Conditions
- Hepatoblastoma, Hepatocellular Carcinoma, Rhabdoid Tumor of Liver, Undifferentiated (Embryonal) Sarcoma of the Liver, Pediatric Liver Cancer, Liver Tumors
- Being tested
- Quality of Life Assessment, Transarterial Radioembolization
- Keywords
- Hepatoblastoma, Hepatocellular carcinoma, Rhabdoid tumor of the liver, Undifferentiated sarcoma of the liver, Liver transplant, unresectable, yttrium 90, Y90, radioembolization, resection, pediatric, cancer, liver tumor
- Medical subject headings
- Hepatoblastoma, Carcinoma, Hepatocellular, Disorders of Sex Development, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of Life AssessmentBehavioural
Evaluation of change of HRQOL survey responses will be performed:
- at baseline (time of treatment) and
- 1 month post treatment
- 6 months post treatment
- 12 months post treatment
- 5 years post-treatment
The HRQOL will be done by phone, mail or email. Responses will be captured and entered into a REDCAP database
Transarterial RadioembolizationRadiation
Deliver catheter directed yttrium-90 directly to liver tumors and assess -Progression Free Survival - Local and Metastatic
- Local Tumor Response by calculating the decreases in tumor size and enhancement after treatment. This will be assessed by modified Response Evaluation Criteria for Solid Tumors (mRECIST).
- Resection Rate following treatment
- Transplant Rate following treatment
- Histologic Response by assessing tumor histopathology in patients who undergo tumor resection or liver transplant
- Biologic Response by monitoring serum tumor markers (e.g. alphafetoprotein-AFP) in AFP secreting tumors
- Review of clinical course post-treatment-rehospitalization rate
| Study group | Role | What they receive |
|---|---|---|
| Standard Treatment | Evaluation of change of HRQOL survey responses will be performed:
* at baseline (time of treatment) and
* 1 month post treatment
* 6 months post treatment
* 12 months post treatment
* 5 years post-treatment
The HRQOL will be done by phone, mail or email. Responses will be captured and entered into a REDCAP database Receives: Behavioral: Quality of Life Assessment; Radiation: Transarterial Radioembolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the impact of TARE-Y90 treatment on health related quality of life (HRQOL)
Evaluation of change of HRQOL survey responses will be performed:
-at baseline (time of treatment)
The HRQOL will be done by phone, mail or email. Responses will be captured and entered into a REDCAP database
Measured: Assessed at baseline/time of treatment
Determine the impact of TARE-Y90 treatment on health related quality of life (HRQOL)
Evaluation of change of HRQOL survey responses will be performed:
- 1 month post treatment
The HRQOL will be done by phone, mail or email. Responses will be captured and entered into a REDCAP database
Measured: Assessed at 1 month post therapy
Determine the impact of TARE-Y90 treatment on health related quality of life (HRQOL)
Evaluation of change of HRQOL survey responses will be performed:
- 6 months post treatment
The HRQOL will be done by phone, mail or email. Responses will be captured and entered into a REDCAP database
Measured: Assessed at 6 months post therapy
Determine the impact of TARE-Y90 treatment on health related quality of life (HRQOL)
Evaluation of change of HRQOL survey responses will be performed:
- 12 months post treatment
The HRQOL will be done by phone, mail or email. Responses will be captured and entered into a REDCAP database
Measured: Assessed at 12 months post therapy
Determine the impact of TARE-Y90 treatment on health related quality of life (HRQOL)
Evaluation of change of HRQOL survey responses will be performed:
- 5 years post-treatment
The HRQOL will be done by phone, mail or email. Responses will be captured and entered into a REDCAP database
Measured: Assessed at 5 years post therapy
Evaluate the efficacy and clinical utility of TARE-Y90 by examining 2 year survival
Deliver catheter directed yttrium-90 directly to liver tumors and assess -Progression Free Survival - Local and Metastatic
-
Measured: Patients will be assessed at 2 years post therapy
Evaluate the efficacy and clinical utility of TARE-Y90 by examining 5 year survival
Deliver catheter directed yttrium-90 directly to liver tumors and assess -Progression Free Survival - Local and Metastatic
Measured: Patients will be assessed at 5 years post therapy
Evaluate the efficacy and clinical utility of TARE-Y90 by examining local tumor response
Deliver catheter directed yttrium-90 directly to liver tumors and assess
-Local Tumor Response by calculating the decreases in tumor size and enhancement after treatment. This will be assessed by modified Response Evaluation Criteria for Solid Tumors (mRECIST).
Measured: Patients will be assessed at the end of treatment which is typically 2-4 months following treatment
Evaluate the efficacy and clinical utility of TARE-Y90 by examining resection rate
Deliver catheter directed yttrium-90 directly to liver tumors and assess
-Resection Rate following treatment
Measured: Patients will be assessed at the end of treatment which is typically 2-4 months following treatment.
Evaluate the efficacy and clinical utility of TARE-Y90 by examining Transplant rate
Deliver catheter directed yttrium-90 directly to liver tumors and assess
-Transplant Rate following treatment
Measured: Patients will be assessed at the end of treatment which is typically 2-4 months following treatment.
Evaluate the efficacy and clinical utility of TARE-Y90 by examining histologic response
Deliver catheter directed yttrium-90 directly to liver tumors and assess
-Histologic Response by assessing tumor histopathology in patients who undergo tumor resection or liver transplant
Measured: Patients will be assessed at the end of treatment which is typically 2-4 months following treatment.
Evaluate the efficacy and clinical utility of TARE-Y90 by examining biologic response
Deliver catheter directed yttrium-90 directly to liver tumors and assess
-Biologic Response by monitoring serum tumor markers (e.g. alphafetoprotein-AFP) in AFP secreting tumors
Measured: Patients will be assessed at the end of treatment which is typically 2-4 months following treatment.
Evaluate the efficacy and clinical utility of TARE-Y90 by examining clinical course
Deliver catheter directed yttrium-90 directly to liver tumors and assess
-Review of clinical course post-treatment-rehospitalization rate
Measured: Patients will be assessed at the end of treatment which is typically 2-4 months following treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2020
- Study start11 Feb 2021
- Primary completion28 Mar 2024
- Study completion28 Mar 2024
Why it stopped: PI left organization and discontinued study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HepatoblastomaStudies 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Alfred I. duPont Hospital for Children
- Responsible party
- Sponsor
- Investigators
- Howard Katzenstein, Principal investigator, Nemours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04315883
- Sponsor's protocol ID
- NEMOURS TARE-Y90: ST1901
- Status last verified
- Jun 2024
- First submitted
- 2 Mar 2020
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aguado A, Ristagno R, Towbin AJ, Gupta A, Haberle S, Qi Z, Patel MN, Kukreja KU, Tiao GM, Geller JI. Transarterial radioembolization with yttrium-90 of unresectable primary hepatic malignancy in children. Pediatr Blood Cancer. 2019 Jul;66(7):e27510. doi: 10.1002/pbc.27510. Epub 2018 Nov 8.
PubMed 30406959
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes and Quality of Life After Transarterial Radioembolization With Yttrium-90 (TARE-Y90) in Children, Adolescents, and Young Adults With Liver Tumors
- ClinicalTrials.gov ID
- NCT04315883
- Acronym / sponsor ID
- NEMOURS TARE-Y90: ST1901
- Conditions
- Hepatoblastoma, Hepatocellular Carcinoma, Rhabdoid Tumor of Liver, Undifferentiated (Embryonal) Sarcoma of the Liver, Pediatric Liver Cancer, Liver Tumors
- Keywords
- Hepatoblastoma, Hepatocellular carcinoma, Rhabdoid tumor of the liver, Undifferentiated sarcoma of the liver, Liver transplant, unresectable, yttrium 90, Y90
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI left organization and discontinued study
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Collaborators
- Alfred I. duPont Hospital for Children
- Study start
- 11 Feb 2021 (actual)
- Primary completion
- 28 Mar 2024 (actual)
- Study completion
- 28 Mar 2024 (actual)
- First posted
- 20 Mar 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.
This study will be performed to evaluate the Clinical Outcomes and Quality of Life after Transarterial Radioembolization with Yttrium-90 (TARE-Y90) in Children, Adolescents, and Young Adults with Liver Tumors. The treatment and techniques used here are well established in adults.
The purpose of this study is to evaluate:
- the response to treatment and clinical outcomes of treatment with TARE Y-90 as part of standard therapy and
- to assess the change in the patient's quality of life before, during and after treatment with TARE-Y90
Detailed description
- Referral to Nemours Liver Tumor Program is made by the primary team (oncologist/surgeon).
- Phone discussion between the Nemours Liver Tumor Program Team will occur with the referring team about the patient.
- Phone call between the Nemours Liver Tumor Program Team and the family will occur prior to any visit to discuss the potential plan of care and the basics of the TARE-Y90 procedure and the Quality of Life surveys.
Review of medical records provided by referring institution will be done by the Nemours Liver Tumor Program Team including:
History, Scans-actual imaging required, Path report-slide submission required, Roadmaps, Labs, Other pertinent medical history and records
-Visit to Nemours/AI DuPont Children's Hospital for initial consultation will be arranged by the Nemours Liver Tumor Program Team.
The patient and family will meet with the team including:
Liver transplant surgeon (Dr Dunn), Interventional Radiologist (Dr Aguado), Social worker, Child life specialist, Pediatric oncologist (Dr Gresh - on site, Dr Katzenstein by telemedicine)
- Attempt will be made to schedule the pre-planning angiogram as part of initial visit (2nd day of visit). The angiogram requires the following 3-4 hours (mapping of blood vessels in and around tumor - determines whether patient can receive Y90, Angiogram is done with the patient sedated and having been after midnight the night before, The patient is expected to be discharged on the same day of the angiogram- no admit is planned but occasionally the patient may need overnight observation to occur due to age of the patient or the length of the procedure.
- Return to home.
- Potential additional single cycle of chemotherapy may be given prior to return to Nemours for Y90.
All further Chemotherapy Care is coordinated with Nemours Liver Tumor oncologists
-A 2nd visit to AIDHC will occur for TARE-Y90 treatment: The procedure lasts about 2-3 hours. There is no planned admit but possible if any problems occur.
- 2 weeks post procedure a phone call follow-up after treatment will occur with the Nemours team
- 2 weeks post procedure the patient may resume chemotherapy when cleared by the Nemours team
- 4-6 weeks post Y90 treatment - a repeat CT/MRI will be done as well as lab tests.
- If possible, the CT/MRI to be done at AIDHC/Nemours but can be done locally if travel barriers exist.
- If the tumor is now resectable, planning will be made for resection at AIDHC/Nemours.
- Evaluation and change of HRQOL survey responses will be performed at baseline (time of treatment) and 1, 6, 12 months and 5 years post-treatment. These surveys will be done by phone, mail or email. Responses will be captured and entered into a REDCAP database
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard Treatment | – | Behavioral: Quality of Life Assessment, Radiation: Transarterial RadioembolizationEvaluation of change of HRQOL survey responses will be performed: * at baseline (time of treatment) and * 1 month post treatment * 6 months post treatment * 12 months post treatment * 5 years post-treatment The HRQOL will be done by phone, mail or email. Responses will be captured and entered into a REDCAP database |
Who may qualify
- Ages
- 0 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric and Young adult patients with liver tumors
Key inclusion criteria (3 listed)
- Boys and girls age < 21 years of age
- History of liver tumor
- Meet criteria for treatment with TARE-Y90
Key exclusion criteria (1 listed)
- • Inability to complete required study procedures.
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 |
|---|---|---|
| Quality of Life AssessmentEvaluation of change of HRQOL survey responses will be performed: * at baseline (time of treatment) and * 1 month post treatment * 6 months post treatment * 12 months post treatment * 5 years post-treatment The HRQOL will be done by phone, mail or email. Responses will be captured and entered into a REDCAP database | Behavioural | Standard Treatment |
| Transarterial RadioembolizationDeliver catheter directed yttrium-90 directly to liver tumors and assess -Progression Free Survival - Local and Metastatic * Local Tumor Response by calculating the decreases in tumor size and enhancement after treatment. This will be assessed by modified Response Evaluation Criteria for Solid Tumors (mRECIST). * Resection Rate following treatment * Transplant Rate following treatment * Histologic Response by assessing tumor histopathology in patients who undergo tumor resection or liver transplant * Biologic Response by monitoring serum tumor markers (e.g. alphafetoprotein-AFP) in AFP secreting tumors * Review of clinical course post-treatment-rehospitalization rate | Radiation | Standard Treatment |
Primary outcome
Determine the impact of TARE-Y90 treatment on health related quality of life (HRQOL)
Time frame: Assessed at baseline/time of treatment
Evaluation of change of HRQOL survey responses will be performed: -at baseline (time of treatment) The HRQOL will be done by phone, mail or email. Responses will be captured and entered into a REDCAP database
Determine the impact of TARE-Y90 treatment on health related quality of life (HRQOL)
Time frame: Assessed at 1 month post therapy
Evaluation of change of HRQOL survey responses will be performed: - 1 month post treatment The HRQOL will be done by phone, mail or email. Responses will be captured and entered into a REDCAP database
Determine the impact of TARE-Y90 treatment on health related quality of life (HRQOL)
Time frame: Assessed at 6 months post therapy
Evaluation of change of HRQOL survey responses will be performed: - 6 months post treatment The HRQOL will be done by phone, mail or email. Responses will be captured and entered into a REDCAP database
Determine the impact of TARE-Y90 treatment on health related quality of life (HRQOL)
Time frame: Assessed at 12 months post therapy
Evaluation of change of HRQOL survey responses will be performed: - 12 months post treatment The HRQOL will be done by phone, mail or email. Responses will be captured and entered into a REDCAP database
Determine the impact of TARE-Y90 treatment on health related quality of life (HRQOL)
Time frame: Assessed at 5 years post therapy
Evaluation of change of HRQOL survey responses will be performed: - 5 years post-treatment The HRQOL will be done by phone, mail or email. Responses will be captured and entered into a REDCAP database
Evaluate the efficacy and clinical utility of TARE-Y90 by examining 2 year survival
Time frame: Patients will be assessed at 2 years post therapy
Deliver catheter directed yttrium-90 directly to liver tumors and assess -Progression Free Survival - Local and Metastatic -
Evaluate the efficacy and clinical utility of TARE-Y90 by examining 5 year survival
Time frame: Patients will be assessed at 5 years post therapy
Deliver catheter directed yttrium-90 directly to liver tumors and assess -Progression Free Survival - Local and Metastatic
Evaluate the efficacy and clinical utility of TARE-Y90 by examining local tumor response
Time frame: Patients will be assessed at the end of treatment which is typically 2-4 months following treatment
Deliver catheter directed yttrium-90 directly to liver tumors and assess -Local Tumor Response by calculating the decreases in tumor size and enhancement after treatment. This will be assessed by modified Response Evaluation Criteria for Solid Tumors (mRECIST).
Evaluate the efficacy and clinical utility of TARE-Y90 by examining resection rate
Time frame: Patients will be assessed at the end of treatment which is typically 2-4 months following treatment.
Deliver catheter directed yttrium-90 directly to liver tumors and assess -Resection Rate following treatment
Evaluate the efficacy and clinical utility of TARE-Y90 by examining Transplant rate
Time frame: Patients will be assessed at the end of treatment which is typically 2-4 months following treatment.
Deliver catheter directed yttrium-90 directly to liver tumors and assess -Transplant Rate following treatment
Evaluate the efficacy and clinical utility of TARE-Y90 by examining histologic response
Time frame: Patients will be assessed at the end of treatment which is typically 2-4 months following treatment.
Deliver catheter directed yttrium-90 directly to liver tumors and assess -Histologic Response by assessing tumor histopathology in patients who undergo tumor resection or liver transplant
Evaluate the efficacy and clinical utility of TARE-Y90 by examining biologic response
Time frame: Patients will be assessed at the end of treatment which is typically 2-4 months following treatment.
Deliver catheter directed yttrium-90 directly to liver tumors and assess -Biologic Response by monitoring serum tumor markers (e.g. alphafetoprotein-AFP) in AFP secreting tumors
Evaluate the efficacy and clinical utility of TARE-Y90 by examining clinical course
Time frame: Patients will be assessed at the end of treatment which is typically 2-4 months following treatment.
Deliver catheter directed yttrium-90 directly to liver tumors and assess -Review of clinical course post-treatment-rehospitalization rate
Results and safety
The study was stopped early (reason given: PI left organization and discontinued study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Results publication: PubMed 30406959Aguado A, Ristagno R, Towbin AJ, Gupta A, Haberle S, Qi Z, Patel MN, Kukreja KU, Tiao GM, Geller JI. Transarterial radioembolization with yttrium-90 of unresectable primary hepatic malignancy in children. Pediatr Blood Cancer. 2019 Jul;66(7):e27510. doi: 10.1002/pbc.27510. Epub 2018 Nov 8.
- Individual participant dataSharing planned: No
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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.
Howard Katzenstein principal investigator
Nemours
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatoblastoma and Hepatocellular Carcinoma, run by Nemours Children's Clinic 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 3 inclusion and 1 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: stopped early, as of the sponsor's last update on 12 Jun 2024. 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 was stopped early (reason given: PI left organization and discontinued study). Results are not available in the source record.
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?
Determine the impact of TARE-Y90 treatment on health related quality of life (HRQOL) (time frame: Assessed at baseline/time of treatment). The study lists 13 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 NCT04315883, which also lists 1 linked publication.
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 12 Jun 2024.