AI mammogram risk scores climbed for six years before breast cancer diagnosis in a 54,014-woman study
AI risk scores read from mammograms rose from a median 2.1 to 6.6 over the six years before breast cancer diagnosis in a Radiology study of 54,014 women. The retrospective result supports tracking each woman's score across screening rounds and leaves open what a rise should trigger.
The Board Room · Leadership desk
Among cancer patients, the median AI risk score rose from 2.1 in the first five to six years of the study period to 6.6 at the index exam.
| Measure | Value | As of | Claim |
|---|---|---|---|
| First five to six years of study | 2.1 median score | 8 | |
| At index exam | 6.6 median score | 8 |
What happened
- The retrospective study used screening exams from 2009 to 2019 at six imaging sites spanning urban tertiary, community and rural practices.
- After exclusions the cohort held 817 women diagnosed with cancer and 53,197 cancer-free controls, at a median age of 61.
- Each woman contributed one index exam and up to six prior annual mammograms, 158,807 exams in all, with a median of three per woman.
- A validated, open-source deep learning model scored every mammogram from the image alone, with no demographic, clinical or prior-imaging data.
- Of the cancers, 451 were invasive, 118 were ductal carcinoma in situ and 248 were of unknown type.
Why it matters
- decision Programmes buying AI risk tools now have to specify whether the tool scores each exam alone or also reads every woman's prior images, a choice that is hard to undo once older exams are out of reach.
- constraint A trajectory needs history, so women new to a programme or moving between providers would get the least from a tracked score.
- capability Because the score uses only the image, a programme could build trajectories from mammogram archives it already holds, without collecting questionnaires or family history.
The cancer group's starting score matters more than its final one. Five to six years out, its median was 2.1 [8], inside the 1.8 to 2.2 band the cancer-free women held at every time point [9][17]. On medians alone, one early reading would not have separated the two groups. The gap opened as the scores moved, and by the index exam the cancer group's median had roughly tripled, to 6.6 [8][16]. "The increase in scores among cancer patients was detectable as early as six years prior to diagnosis and became more pronounced over time," said Constance Lehman, the lead researcher [10][12].
The 6.6 depends on how the study defined its index exam: the last screening mammogram in the year before diagnosis [5]. Of the 817 cancers, 682, or 83%, were detected at screening [7]. For most of those women, we think, the index exam is the screen that found the cancer, so the top of the curve partly measures disease already visible on the image. The earlier, smaller rise is the part a risk programme could act on, and the release reports it as group medians [8].
Medians describe how two populations moved. Whether a rise in one woman's score predicts her cancer well enough to change her care is a separate question, and a retrospective cohort is where that test begins [2]. The pool also narrowed before analysis. Some 89,882 patients were initially included [3], and about 40% were excluded [18]. Lehman's own wording on clinical value is measured: she said changes in the scores "may provide additional information" [15].
The release identifies Lehman as a professor of radiology at Harvard Medical School and chief executive of Clairity, Inc. [12]. The model her team ran is described as validated and open-source [6]. Her case for image-based risk rests on the women conventional models miss. "This is exciting, because 85% of women diagnosed with breast cancer do not have a significant family history of breast cancer or known genetic mutations," she said [11]. The release adds that traditional risk models have limited discriminatory ability in population-based screening [13].
The timescales separate cleanly for a screening director. Nothing in this study justifies changing recall or supplemental-imaging rules on a rising score this quarter, because its design was retrospective [2]. Whether acting on a trajectory finds cancers earlier than routine screening would is the longer question, and answering it needs a prospective trial.
What to watch
- A prospective trial testing whether acting on a rising AI score changes stage at diagnosis or interval-cancer rates.
- Individual-level accuracy figures for the change in score, from this team or an independent cohort, beyond group medians.
- Any product or regulatory filing from Clairity, Inc., the company Lehman leads, that uses score trajectories.
Clarity's read
What the record supports and how the coverage leans. The claims behind it follow.
Reality
- Evidence50
- Adoption
- Insufficient
- Hype gap+35
- Incentives60
- Confidence45
Claim ledger
Ranked by verification strength, evidence, and original report placement.
- [1]
Research published in Radiology, a journal of the Radiological Society of North America, found that AI image-based breast cancer risk scores from screening mammograms evolve over time and differ between women who develop cancer and those who do not.
- [2]
The retrospective study included women who underwent screening mammograms between 2009 and 2019 at six imaging sites spanning urban tertiary, community-based and rural practice settings.
- [3]
A total of 239,703 consecutive 2D screening mammograms from 89,882 patients were initially included in the study cohort.
- [4]
After exclusions, the final cohort included 54,014 women (median age 61) with 817 cancer patients and 53,197 cancer-free controls.
- [5]
Each woman contributed one index exam (the final screening mammogram within the year prior to a breast cancer diagnosis, or the final mammogram in the five-year study period for controls) and up to six prior annual mammograms, for a total of 158,807 mammograms; the median number of screening mammograms per woman was three.
- [6]
A validated, open-source image-only deep learning model was applied to all mammograms to generate continuous five-year breast cancer risk scores; no demographic, clinical or historical imaging data were used.
- [7]
Of the 817 women diagnosed with breast cancer within 365 days of their index exam, 682 (83%) were screen-detected cancers and 135 (17%) were interval cancers.
- [8]
Among cancer patients, AI risk scores increased progressively over the six years preceding diagnosis, with the median score increasing from 2.1 in the first five to six years of the study period to 6.6 at the index exam.
- [9]
Cancer-free women exhibited stable scores across all time points, with medians ranging from 1.8 to 2.2 over the study period.
- [10]
"The increase in scores among cancer patients was detectable as early as six years prior to diagnosis and became more pronounced over time."
- [11]
"This is exciting, because 85% of women diagnosed with breast cancer do not have a significant family history of breast cancer or known genetic mutations."
- [12]
Lead researcher Constance D. Lehman, M.D., Ph.D., is professor of radiology at Harvard Medical School and CEO of Clairity, Inc.
- [13]
Traditional risk models have limited discriminatory ability in population-based screening settings.
- [14]
Of the 817 cancers, 451 (55%) were invasive, 118 (14%) were ductal carcinoma in situ and 248 (30%) were of unknown type.
- [15]
Lehman said the findings demonstrate that image-based AI risk scores evolve over time and that "changes in those scores may provide additional information".
- [16]
The cancer group's median score at the index exam was roughly three times its earliest median (6.6 / 2.1 = about 3.1).
- [17]
The cancer group's earliest median score of 2.1 falls inside the 1.8 to 2.2 range of medians recorded for cancer-free women.
- [18]
About 40% of the patients initially included were excluded before the final cohort was formed.
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Sources
1 independent publisher whose own reporting we read for this story.
- retrospective study of over 54,000 women
rsna.org
1 article · October 10, 2026
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