Intra-abdominal MalignanciesACT-LIVERTNCT07320755
Analysis of Computed Tomography Derived Maps for Determining Changes of the Liver Volume After Exposure to Radiotherapy
An observational study of Intra-abdominal Malignancies and Liver as Organ at Risk, run by Assiut University.
Trial summary
Radiotherapy is commonly used to treat cancers involving the liver or nearby organs. While effective, radiation exposure can affect healthy liver tissue and may lead to changes in liver size and function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intra-abdominal Malignancies, Liver as Organ at Risk, Radiation-related Liver Changes
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 31 Dec 2027
- Phase
- Observational
- 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
Study population: Adult patients who have received radiotherapy for liver or nearby tumors and have available pre-treatment and post-treatment CT imaging for assessment of liver volume changes. Both males and females are included, with a minimum age of 18 years and no upper age limit. Participants are selected based on availability of imaging data from routine clinical care.
- Inclusion criteria:
- Adults aged 18 years or older.
- Received radiation therapy (RT) involving the liver (e.g., SBRT, IMRT). The study involves patients in whom the liver was exposed to radiotherapy, either as a direct target (in hepatic-directed treatments as in HCC or liver metastasis) or indirectly as an organ-at-risk (OAR) during irradiation of nearby anatomical regions (as lower lung, gastric, or abdominal sites) where the liver was partially included within the radiation field. The analysis aims to evaluate radiation-induced volumetric changes regardless of whether the liver was the primary target or secondarily affected.
- Availability of paired pre- and post-RT CT scans of sufficient quality.
- 3D dose distribution data from the RT treatment plan.
- Clinical follow-up data, including liver function tests and toxicity records.
- No evidence of major anatomical changes between scans unrelated to RT (e.g., surgery).
- Exclusion criteria:
- Patients with a history of major liver surgery (e.g., resection or transplant) between the pre- and post-RT scans.
- Presence of severe motion artifacts or poor-quality CT scans that hinder accurate image analysis.
- Incomplete or missing 3D radiation dose distribution data.
- Lack of sufficient clinical follow-up information (e.g., liver function tests, toxicity outcomes).
- Concurrent systemic therapies (e.g., chemotherapy or immunotherapy) during the imaging interval that may confound liver volume changes, unless controlled for in analysis.
- Pre-existing liver conditions that could independently alter liver volume (e.g., cirrhosis, advanced hepatic steatosis) if not accounted for.
- Patients under 18 years of age.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Radiotherapy is commonly used to treat cancers involving the liver or nearby organs. While effective, radiation exposure can affect healthy liver tissue and may lead to changes in liver size and function. Monitoring these changes is important to improve treatment planning and reduce the risk of liver-related complications.
This study aims to evaluate changes in liver volume using computed tomography (CT) imaging before and after radiotherapy. By analyzing CT-derived liver maps, the study seeks to better understand how the liver responds to radiation treatment over time.
The study will include patients who undergo radiotherapy and have CT imaging performed as part of their routine clinical care. No additional procedures or treatments will be required for participation. The findings of this study may help improve future radiotherapy planning and patient monitoring by providing better information on liver volume changes following radiation exposure.
Read the detailed description
Radiotherapy plays a central role in the management of primary and metastatic tumors involving the liver or adjacent anatomical regions. Despite advances in radiation delivery techniques, the liver remains a radiosensitive organ, and radiation-induced liver injury continues to be a clinically significant concern. Quantitative assessment of liver volume changes may provide valuable insight into hepatic response and tolerance to radiation exposure.
This study is designed to analyze computed tomography (CT)-derived liver volume maps to assess changes in liver volume following radiotherapy. CT images acquired as part of standard clinical practice will be used to generate volumetric measurements of the liver at baseline and during post-treatment follow-up. Advanced image analysis techniques will be applied to evaluate spatial and global liver volume changes.
The study is observational in nature and does not involve any investigational drugs or devices. All imaging data will be obtained from routine clinical workflows without modification to standard patient care. Demographic, clinical, and treatment-related parameters may be correlated with observed liver volume changes to explore potential associations.
The results of this study are expected to enhance understanding of radiation-related hepatic effects and support optimization of radiotherapy planning strategies. Improved knowledge of liver volume dynamics may contribute to better prediction of treatment-related toxicity and support individualized patient management in future clinical practice.
- Keywords
- liver volume changes after radiotherapy, CT-derived volumetric analysis, Hepatic toxicity prediction, Radiotherapy planning optimization
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Liver Volume After Radiotherapy
The primary outcome is the quantitative change in liver volume measured using computed tomography (CT) imaging before and after radiotherapy. Liver volume will be assessed using standard imaging software and protocols, and changes will be calculated relative to baseline.
Measured: Liver volume changes will be assessed at post-treatment intervals, typically at 1, 3, and 6 months after radiotherapy. If only a single post-treatment scan is available, evaluation will occur approximately 3 months after treatment completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intra-abdominal MalignanciesStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alzahraa Ahmed Fouad, Assiut University
- Investigators
- Amr Farouk Mourad, Prof., Study chair, Assiut UniversityOmar Mostafa Mahmoud Mohammad, Assist Prof., Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07320755
- Sponsor's protocol ID
- RAD-LIVER-2025
- Acronym
- ACT-LIVERT
- Status last verified
- Jan 2026
- First submitted
- 21 Dec 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the study uses retrospective clinical imaging and patient records, and the data contain sensitive health information. Sharing is restricted to protect patient privacy and comply with institutional and ethical regulations.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Computed Tomography Derived Maps for Determining Changes of the Liver Volume After Exposure to Radiotherapy
- ClinicalTrials.gov ID
- NCT07320755
- Acronym / sponsor ID
- ACT-LIVERT / RAD-LIVER-2025
- Keywords
- liver volume changes after radiotherapy, CT-derived volumetric analysis, Hepatic toxicity prediction, Radiotherapy planning optimization
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 Jan 2026 (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.
Radiotherapy is commonly used to treat cancers involving the liver or nearby organs. While effective, radiation exposure can affect healthy liver tissue and may lead to changes in liver size and function. Monitoring these changes is important to improve treatment planning and reduce the risk of liver-related complications.
This study aims to evaluate changes in liver volume using computed tomography (CT) imaging before and after radiotherapy. By analyzing CT-derived liver maps, the study seeks to better understand how the liver responds to radiation treatment over time.
The study will include patients who undergo radiotherapy and have CT imaging performed as part of their routine clinical care. No additional procedures or treatments will be required for participation. The findings of this study may help improve future radiotherapy planning and patient monitoring by providing better information on liver volume changes following radiation exposure.
Detailed description
Radiotherapy plays a central role in the management of primary and metastatic tumors involving the liver or adjacent anatomical regions. Despite advances in radiation delivery techniques, the liver remains a radiosensitive organ, and radiation-induced liver injury continues to be a clinically significant concern. Quantitative assessment of liver volume changes may provide valuable insight into hepatic response and tolerance to radiation exposure.
This study is designed to analyze computed tomography (CT)-derived liver volume maps to assess changes in liver volume following radiotherapy. CT images acquired as part of standard clinical practice will be used to generate volumetric measurements of the liver at baseline and during post-treatment follow-up. Advanced image analysis techniques will be applied to evaluate spatial and global liver volume changes.
The study is observational in nature and does not involve any investigational drugs or devices. All imaging data will be obtained from routine clinical workflows without modification to standard patient care. Demographic, clinical, and treatment-related parameters may be correlated with observed liver volume changes to explore potential associations.
The results of this study are expected to enhance understanding of radiation-related hepatic effects and support optimization of radiotherapy planning strategies. Improved knowledge of liver volume dynamics may contribute to better prediction of treatment-related toxicity and support individualized patient management in future clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who have received radiotherapy for liver or nearby tumors and have available pre-treatment and post-treatment CT imaging for assessment of liver volume changes. Both males and females are included, with a minimum age of 18 years and no upper age limit. Participants are selected based on availability of imaging data from routine clinical care.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Liver Volume After Radiotherapy
Time frame: Liver volume changes will be assessed at post-treatment intervals, typically at 1, 3, and 6 months after radiotherapy. If only a single post-treatment scan is available, evaluation will occur approximately 3 months after treatment completion.
The primary outcome is the quantitative change in liver volume measured using computed tomography (CT) imaging before and after radiotherapy. Liver volume will be assessed using standard imaging software and protocols, and changes will be calculated relative to baseline.
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 9 Jan 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the study uses retrospective clinical imaging and patient records, and the data contain sensitive health information. Sharing is restricted to protect patient privacy and comply with institutional and ethical regulations.
Related trials for Intra-abdominal Malignancies
Active, not recruiting
Structured Post-Operative Pain and Distress Treatment Intervention for Patients Undergoing Surgery for Intra-Abdominal Malignancies
Psychological Distress, Intra-abdominal 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.
Amr Farouk Mourad, Prof. study chair
Assiut University
Omar Mostafa Mahmoud Mohammad, Assist Prof. study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Intra-abdominal Malignancies and Liver as Organ at Risk, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Al Zahraa Ahmed Fouad Hassan, Master Degree (+020-1063704480, zahraa.fouad1998@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Liver Volume After Radiotherapy (time frame: Liver volume changes will be assessed at post-treatment intervals, typically at 1, 3, and 6 months after radiotherapy. If only a single post-treatment scan is available, evaluation will occur approximately 3 months after treatment completion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jan 2026; AzTrials last refreshed its copy on 1 Nov 2026.