Breast CancerNCT07048639
Dosimetric Evaluation of Breathing Impact on PTV and Adjacent Organ At Risk in Breast Cancer Radiotherapy
An observational study of Breast Cancer, run by Superior University at 1 site in Pakistan.
Trial summary
The study is likely an observational study, possibly retrospective or prospective, involving patients with breast cancer undergoing radiotherapy. Read more about this study
- Who is it for?
- Ages 25 to 40 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- 4D-CT (Four-Dimensional Computed Tomography)
- How many people
- 22 participants
- Where
- 1 sitePakistan
- Study dates
- 17 Mar 2025to 1 Mar 2026
- 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 25 to 40 years
- All sexes
- No healthy volunteers
- Adult
Study population: This research study aims to evaluate the dosimetric impact of breathing on planning treatment volume (PTV) and adjacent organs at risk (OARs) in breast cancer radiotherapy. The study seeks to quantify the effects of breathing motion on radiation dose distribution, which is crucial for ensuring effective treatment and minimizing side effects.
Who may be able to join
- Patient of breast cancer.
- age 25-40
Who cannot join
- Patients without breast cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dosimetric Evaluation of Breathing Impact on Planning Treatment Volumne and Adjacent Organ At Risk in Breast Cancer Radiotherapy
The study is likely an observational study, possibly retrospective or prospective, involving patients with breast cancer undergoing radiotherapy.
Read the detailed description
Patients with breast cancer scheduled for radiotherapy will be selected based on specific inclusion and exclusion criteria.
Patients will undergo imaging studies, such as computed tomography (CT) scans, to define the target volumes and OARs.
The study aims to provide insights into the dosimetric impact of breathing motion on PTV and OARs in breast cancer radiotherapy, which can inform strategies to improve treatment planning and delivery.
- Conditions
- Breast Cancer
- Being tested
- 4D-CT (Four-Dimensional Computed Tomography)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4D-CT (Four-Dimensional Computed Tomography)Diagnostic test
To assess tumor and organ motion during breathing
| Study group | Role | What they receive |
|---|---|---|
| 4D-CT (Four-Dimensional Computed Tomography) | Not described Receives: Diagnostic Test: 4D-CT (Four-Dimensional Computed Tomography) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician's Global Assessment (PGA) Scale with scoring details
The Physician's Global Assessment (PGA) scale is a tool used by physicians to evaluate the overall severity of a patient's disease. It's a subjective assessment, typically on a scale of 0 to 3 or 0 to 4, with higher scores indicating more severe disease activity. The PGA focuses on the overall disease activity, considering both the severity of active manifestations and relevant laboratory results, excluding organ damage and subjective findings unrelated to disease activity.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start17 Mar 2025
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Superior 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07048639
- Sponsor's protocol ID
- MSAHSW/Batch-Fall23/904
- Status last verified
- Jun 2025
- First submitted
- 24 Jun 2025
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dosimetric Evaluation of Breathing Impact on Planning Treatment Volumne and Adjacent Organ At Risk in Breast Cancer Radiotherapy
- ClinicalTrials.gov ID
- NCT07048639
- Acronym / sponsor ID
- MSAHSW/Batch-Fall23/904
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 2 Jul 2025 (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.
The study is likely an observational study, possibly retrospective or prospective, involving patients with breast cancer undergoing radiotherapy.
Detailed description
Patients with breast cancer scheduled for radiotherapy will be selected based on specific inclusion and exclusion criteria.
Patients will undergo imaging studies, such as computed tomography (CT) scans, to define the target volumes and OARs.
The study aims to provide insights into the dosimetric impact of breathing motion on PTV and OARs in breast cancer radiotherapy, which can inform strategies to improve treatment planning and delivery.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 4D-CT (Four-Dimensional Computed Tomography) | – | Diagnostic Test: 4D-CT (Four-Dimensional Computed Tomography) |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This research study aims to evaluate the dosimetric impact of breathing on planning treatment volume (PTV) and adjacent organs at risk (OARs) in breast cancer radiotherapy. The study seeks to quantify the effects of breathing motion on radiation dose distribution, which is crucial for ensuring effective treatment and minimizing side effects.
Key inclusion criteria (2 listed)
- Patient of breast cancer.
- age 25-40
Key exclusion criteria (1 listed)
- Patients without breast cancer
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 |
|---|---|---|
| 4D-CT (Four-Dimensional Computed Tomography)To assess tumor and organ motion during breathing | Diagnostic test | 4D-CT (Four-Dimensional Computed Tomography) |
Primary outcome
Physician's Global Assessment (PGA) Scale with scoring details
Time frame: 12 Months
The Physician's Global Assessment (PGA) scale is a tool used by physicians to evaluate the overall severity of a patient's disease. It's a subjective assessment, typically on a scale of 0 to 3 or 0 to 4, with higher scores indicating more severe disease activity. The PGA focuses on the overall disease activity, considering both the severity of active manifestations and relevant laboratory results, excluding organ damage and subjective findings unrelated to disease activity.
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 2 Jul 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Superior University at 1 site in Pakistan.
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 2 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: under way, not looking for participants, as of the sponsor's last update on 2 Jul 2025. 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 Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physician's Global Assessment (PGA) Scale with scoring details (time frame: 12 Months). 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 2 Jul 2025.