Breast CancerNCT05141279
Accuracy Of Contrast Enhanced Mamography in Predicting Response of Breast Cancer Post Neoadjuvant Chemotherapy
An observational study of Breast Cancer, run by Assiut University.
Trial summary
The aim of this work to evaluate the accuracy of contrast enhanced spectral mamography in predicting the response to NAC and assessment of residual disease in breast cancer patients Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Cancer
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2021to 1 Jan 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: 50 patients who will attend to outpatient surgical and oncology clinicS of Assiut university and diagnosed by biopsy as breast cancer
Who may be able to join
- patient confirmed diagnosed by early breast cancer decided to received neoadjuvant treatment
- locally advanced breast cancer
- operable metastatic breast cancer
Who cannot join
- patient not candidate for NAC
- contrast allergy
- renal impairment
- pregnancy
About this study
Official title: Contrast Enhanced Mamography in Predicting Response of Breast Cancer Post Neoadjuvant Chemotherapy
The aim of this work to evaluate the accuracy of contrast enhanced spectral mamography in predicting the response to NAC and assessment of residual disease in breast cancer patients
Read the detailed description
This a prospective series ,will be performed for 50 patients diagnosed by biopsy as breast cancer who will be scheduled for surgery after completing the full coarse of neoadjuvant chemotherapy
- Conditions
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Stable | |
| 2 | Partial response | |
| 3 | Moderate response | |
| 4 | Excellent response | |
| 5 | Complete response |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of contrast enhanced spectral mamography in the predicting of pathological response to NAC and assessment residual disease in breast cancer patients
Measured: Basline
Secondary outcomes (1)
Assess best imaging modalities in pedict post neoadjuvant response
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start1 Dec 2021 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Jan 2024 (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 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
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DMAhmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05141279
- Sponsor's protocol ID
- CESM in breast cancer
- Status last verified
- Nov 2021
- First submitted
- 19 Nov 2021
- Last updated
- 2 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast Enhanced Mamography in Predicting Response of Breast Cancer Post Neoadjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT05141279
- Acronym / sponsor ID
- CESM in breast cancer
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 2 Dec 2021 (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 aim of this work to evaluate the accuracy of contrast enhanced spectral mamography in predicting the response to NAC and assessment of residual disease in breast cancer patients
Detailed description
This a prospective series ,will be performed for 50 patients diagnosed by biopsy as breast cancer who will be scheduled for surgery after completing the full coarse of neoadjuvant chemotherapy
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Stable |
| 2 | – | –Partial response |
| 3 | – | –Moderate response |
| 4 | – | –Excellent response |
| 5 | – | –Complete response |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- 50 patients who will attend to outpatient surgical and oncology clinicS of Assiut university and diagnosed by biopsy as breast cancer
Key inclusion criteria (3 listed)
- patient confirmed diagnosed by early breast cancer decided to received neoadjuvant treatment
- locally advanced breast cancer
- operable metastatic breast cancer
Key exclusion criteria (4 listed)
- patient not candidate for NAC
- contrast allergy
- renal impairment
- pregnancy
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
Accuracy of contrast enhanced spectral mamography in the predicting of pathological response to NAC and assessment residual disease in breast cancer patients
Time frame: Basline
1 secondary outcome
Assess best imaging modalities in pedict post neoadjuvant response
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2021.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, 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?
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: status not confirmed, as of the sponsor's last update on 2 Dec 2021. 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?
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?
Accuracy of contrast enhanced spectral mamography in the predicting of pathological response to NAC and assessment residual disease in breast cancer patients (time frame: Basline). 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 Dec 2021.