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NCT05796219: ALDRAM
Automated Low Dose Risk Assessment Mammography (ALDRAM)
NA trial testing Low dose mammogram in Breast Cancer in 154 participants. Completed in 16 February 2023.
5 May 2020
Quick facts
| Lead sponsor | Manchester University NHS Foundation Trust |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | screening |
| Enrollment | 154 |
| Start date | 22 February 2019 |
| Primary completion | 5 May 2020 |
| Estimated completion | 16 February 2023 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Low dose mammogram
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
Sponsor
Manchester University NHS Foundation Trust
Who can join
Adults 30 to 45, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Breast cancer (BC) is the commonest cause of death in young women. Breast screening in women aged 35-45, at increased risk due to their family history, has been shown to improve survival. However, 80% of women who develop BC do not have a family history. Numerous studies have shown that high mammographic density (MD) is one of the strongest risk factors for BC development. Full field digital mammography (FFDM) can be used to assess MD, however it is not recommended for population BC screening in those \<40 years of age due to the concerns about the use of ionising radiation. Safe and accurate high throughput methods to quantify MD in young women are thus required to improve risk prediction and reduce BC mortality. This study aims to develop a low dose mammogram, with quantification of density using artificial intelligence, to facilitate high throughput risk assessment in young women. 600 women aged 30-45, previously identified as being at increased risk of BC and attending for annual mammography at The Nightingale Centre will be recruited. Participants will undergo FFDM of the right breast as usual, however, following acquisition of the craniocaudal (CC) view, the breast will remain compressed and the mammogram dose reduced by 90% to deliver a LD mammogram. This process will be repeated for the right medio-lateral oblique (MLO) view. The left breast FFDM will proceed as normal. It is estimated that each extra exposure will take 1-2 minutes only. Deep machine learning methods will be used to define the relationship between standard FFDM views and their low dose counterparts and determine which view (CC vs MLO) provides the best correlation to be taken forward to the next stage of the research.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05796219
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Manchester University NHS Foundation Trust trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05796219 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Manchester University NHS Foundation Trust
- Last refreshed: 3 April 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05796219.
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