Randomized trial of surveillance with abbreviated MRI in women with a personal history of breast cancer- impact on patient anxiety and cancer detection

Abstract

Background: Abbreviated breast MRI (A-MRI) substantially reduces the image acquisition and reading times and has been reported to have similar diagnostic accuracy as a full diagnostic protocol but has not been evaluated prospectively with respect to impact on psychological distress in women with a prior history of breast cancer (PHBC). This study aimed to determine if surveillance mammography (MG) plus A-MRI reduced psychological distress and if A-MRI improved cancer detection rates (CDR) as compared to MG alone.

Methods: This prospective controlled trial of parallel design was performed at a tertiary cancer center on asymptomatic women with PHBC who were randomized into two groups: routine surveillance with MG or intervention of MG plus A-MRI in a 1:1 ratio. Primary outcome was anxiety measured by four validated questionnaires at three different time-points during the study. Other parameters including CDR and positive predictive value for biopsy (PPV3) were compared between imaging modalities of MG and A-MRI. Tissue diagnoses or 1 year of follow-up were used to establish the reference standard. Linear mixed models were used to analyze anxiety measures and Fisher's exact test to compare imaging outcomes.

Results: One hundred ninety-eight patients were allocated to either MG alone (94) or MG plus A-MRI (104). No significant group difference emerged for improvement in trait anxiety, worry and perceived health status (all Time-by-surveillance group interaction ps > .05). There was some advantage of A-MRI in reducing state anxiety at Time 2 (p < .05). Anxiety scores in all questionnaires were similarly elevated in both groups (50.99 ± 4.6 with MG alone vs 51.73 ± 2.56 with MG plus A-MRI, p > 0.05) and did not change over time. A-MRI detected 5 invasive cancers and 1 ductal carcinoma in situ (DCIS), and MG detected 1 DCIS. A-MRI had higher incremental CDR (48/1000(5/104) vs MG 5/1000(1/198, p = 0.01)) and higher biopsy rates (19.2% (20/104) vs MG 2.1% (2/94), p < 0.00001) with no difference in PPV3 (A-MRI 28.6% (6/21) vs MG 16.7% (1/6, p > .05).

Conclusion: There was no significant impact of A-MRI to patient anxiety or perceived health status. Compared to MG alone, A-MRI had significantly higher incremental cancer detection in PHBC. Despite a higher rate of biopsies, A-MRI had no demonstrable impact on anxiety, worry, and perceived health status.

Trial registration: ClinicalTrials.gov ( NCT02244593 ). Prospectively registered on Sept. 14, 2014.

Keywords: Abbreviated; Anxiety; Breast cancer; MRI; Mammography.

Conflict of interest statement

The author(s) declare(s) that they have no competing interests.

© 2022. The Author(s).

Figures

Fig. 1

CONSORT Flow diagram of trial

Fig. 2

Woman (60–70 years old) with PHBC treated by right mastectomy 12 years prior to study. A MLO and B CC Left surveillance mammograms show heterogeneously dense breast tissue (BI-RADS C) with normal, stable findings. C Axial 3D MIP at 2 min post contrast performed after mammograms shows right mastectomy with no chest wall abnormalities and an irregular 4.5 cm enhancing mass (circle) in the medial left breast reported as BI-RADS 4B. The second circumscribed mass in the lateral breast corresponded with a benign fibroadenoma (arrow). D Axial 2 min post contrast subtracted image demonstrates the spiculated enhancing mass in the upper medial quadrant of the left breast (circle). E Axial image from MRI biopsy demonstrates the needle sampling the mass (circle), diagnostic for pleomorphic lobular carcinoma in situ, which was confirmed at surgical excision to be associated with invasive lobular carcinoma