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Clinical Trial
. 2022 Dec;23(12):1499-1507.
doi: 10.1016/S1470-2045(22)00642-8. Epub 2022 Nov 4.

Intra-individual comparison of 18F-sodium fluoride PET-CT and 99mTc bone scintigraphy with SPECT in patients with prostate cancer or breast cancer at high risk for skeletal metastases (MITNEC-A1): a multicentre, phase 3 trial

François Bénard  1 , Sara Harsini  2 , Don Wilson  3 , Katherine Zukotynski  4 , Gad Abikhzer  5 , Eric Turcotte  6 , Mariève Cossette  7 , Ur Metser  8 , Jonathan Romsa  9 , Montgomery Martin  3 , Colin Mar  3 , Fred Saad  10 , Jean-Paul Soucy  11 , Bernhard J Eigl  2 , Peter Black  12 , Andra Krauze  2 , Steven Burrell  13 , Alan Nichol  2 , Jean-Claude Tardif  7
Affiliations
Clinical Trial

Intra-individual comparison of 18F-sodium fluoride PET-CT and 99mTc bone scintigraphy with SPECT in patients with prostate cancer or breast cancer at high risk for skeletal metastases (MITNEC-A1): a multicentre, phase 3 trial

François Bénard et al. Lancet Oncol. 2022 Dec.

Abstract

Background: Detection of skeletal metastases in patients with prostate cancer or breast cancer remains a major clinical challenge. We aimed to compare the diagnostic performance of 99mTc-methylene diphosphonate (99mTc-MDP) single-photon emission CT (SPECT) and 18F-sodium fluoride (18F-NaF) PET-CT for the detection of osseous metastases in patients with high-risk prostate or breast cancer.

Methods: MITNEC-A1 was a prospective, multicentre, single-cohort, phase 3 trial conducted in ten hospitals across Canada. Patients aged 18 years or older with breast or prostate cancer with a WHO performance status of 0-2 and with high risk or clinical suspicion for bone metastasis, but without previously documented bone involvement, were eligible. 18F-NaF PET-CT and 99mTc-MDP SPECT were done within 14 days of each other for each participant. Two independent reviewers interpreted each modality without knowledge of other imaging findings. The primary endpoint was the overall accuracy of 99mTc-MDP SPECT and 18F-NaF PET-CT scans for the detection of bone metastases in the per-protocol population. A combination of histopathological, clinical, and imaging follow-up for up to 24 months was used as the reference standard to assess the imaging results. Safety was assessed in all enrolled participants. This study is registered with ClinicalTrials.gov, NCT01930812, and is complete.

Findings: Between July 11, 2014, and March 3, 2017, 290 patients were screened, 288 of whom were enrolled (64 participants with breast cancer and 224 with prostate cancer). 261 participants underwent both 18F-NaF PET-CT and 99mTc-MDP SPECT and completed the required follow-up for statistical analysis. Median follow-up was 735 days (IQR 727-750). Based on the reference methods used, 109 (42%) of 261 patients had bone metastases. In the patient-based analysis, 18F-NaF PET-CT was more accurate than 99mTc-MDP SPECT (84·3% [95% CI 79·9-88·7] vs 77·4% [72·3-82·5], difference 6·9% [95% CI 1·3-12·5]; p=0·016). No adverse events were reported for the 288 patients recruited.

Interpretation: 18F-NaF has the potential to displace 99mTc-MDP as the bone imaging radiopharmaceutical of choice in patients with high-risk prostate or breast cancer.

Funding: Canadian Institutes of Health Research.

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Conflict of interest statement

Declaration of interests FB is co-founder, director, consultant, and shareholder of Alpha-9 Theranostics, a radiopharmaceutical company, outside the submitted work. UM reports consulting fees from POINT Biopharma, outside the submitted work. KZ reports grants or contracts from Canadian Cancer Society, Ontario Institute for Cancer Research, Invicro, General Electric, Fusion Pharmaceuticals, and Centre for Probe Development and Commercialization; payment or honoraria for lectures from Jubilant Draximage and Canadian Urological Association; and leadership or fiduciary role in the Society of Nuclear Medicine and Molecular Imaging (SNMMI), American College of Nuclear Medicine, and Intersocietal Accreditation Commission, all outside the submitted work. GA reports a leadership role in the SNMMI, outside the submitted work. FS reports grants or contracts from Astellas, AstraZeneca, Bayer, Janssen, Merck, Myovant, Pfizer, and Sanofi; consulting fees from Astellas, AstraZeneca, Bayer, Janssen, Merck, Myovant, Pfizer, Sanofi, Tolmar, and Abbvie; and payment or honoraria for lectures from Astellas, AstraZeneca, Bayer, Janssen, Merck, Myovant, Pfizer, Sanofi, Tolmar, and Abbvie, all outside the submitted work. BJE reports consulting fees from Seagen Canada, Pfizer, Merck, EMD Serono, and Bayer; payment or honoraria for lectures from Pfizer, EMD Serono, and Merck; and support for attending meetings from EMD Serono, all outside the submitted work. PB reports participation in advisory boards of Janssen, Merck, Roche/Genentech, BMS, Urogen, Asieris, EMD Serono, Bayer, Astellas, AbbVie, AstraZeneca, Ferring, Fergene, Sanofi, H3-Biomedicine, Nonagen, miR Scientific, Stimit, Prokarium, Tolmar, Protara Therapeutics, Verity, Sesen Biosciences; consulting fees from NanOlogy; and payment or honoraria for lectures from Janssen, Bayer, TerSera, Ferring, Pfizer, H3-Biomedicine, and Biosyent, all outside the submitted work. All other authors declare no competing interests.

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