The study, “Detecting Endometriosis Expressed Integrins using Technetium-99m (DETECT)”, is a collaboration between clinical radiopharmaceutical company, Serac Healthcare Ltd and the Nuffield Department of Women’s & Reproductive Health.
About the study
The study evaluated 19 individuals with suspected or confirmed pelvic or thoracic endometriosis. Participants underwent preoperative SPECT-CT imaging, a non-invasive scan, following intravenous administration of 99mTc-maraciclatide.
This imaging agent binds to αvβ3 integrins, which are upregulated during angiogenesis (the formation of new blood vessels), a key feature of inflammatory diseases such as endometriosis. By visualising this process, the scan can detect areas of disease.
The study found that this non-invasive approach performed comparably to laparoscopic surgery in detecting endometriosis.
Why it Matters
Endometriosis is a common inflammatory disease affecting an estimated 190 million women worldwide (about 1 in 10 women of childbearing age). It occurs when tissues similar to the lining of the uterus are found outside the uterus, predominantly in the pelvis, but sometimes on other bodily areas, e.g., the lungs. The presence of this ectopic endometrial tissue can lead to inflammation and distortion of normal anatomy, which can cause significant pain and infertility.
Despite the prevalence of the disease and pain it causes, those with endometriosis typically experience an 8-12 year delay to diagnosis, requiring numerous appointments to physicians and hospitals, and undergoing multiple scans.
Superficial Peritoneal Endometriosis (SPE), which is found on the peritoneum (a continuous membrane that lines the abdominal cavity and covers the abdominal organs) accounts for about 80% of all endometriosis diagnoses by laparoscopy, making it the most common form. It is also the earliest stage of the disease.
Currently, SPE can only be identified accurately by surgery; however, 40% of these surgical procedures are negative, indicating that many women are undergoing unnecessary invasive procedures.
Key findings:
- A high correlation between the locations of maraciclatide uptake and laparoscopy was observed across all types of endometriotic lesions, including superficial peritoneal endometriosis.
- Reliable visualisation and accurate detection of the disease using 99mTc-maraciclatide, which is often missed by conventional imaging methods such as MRI scans.
- Imaging results were consistent with the surgical presence or absence of endometriosis in 16/19 cases, including detection in 14/17 surgically confirmed cases (with two cases of thoracic endometriosis).
- No false positives were reported, demonstrating 100% specificity.
- Lesions were detected across all endometriosis subtypes, regardless of current treatments.
- 99mTc-maraciclatide was well tolerated with high patient acceptability
These exciting findings indicate that maraciclatide offers a highly promising diagnostic and monitoring tool, particularly for superficial peritoneal endometriosis, which is the most common and yet the hardest type of endometriosis to identify. We are hugely grateful to the patients who have participated in the DETECT study without whom investigating this diagnostic approach would not have been possible.
– Dr Tatjana Gibbons, lead author on the paper and investigator on the study from the Nuffield Department of Women’s and Reproductive Health, University of Oxford
Superficial peritoneal endometriosis (SPE), the most prevalent subtype of endometriosis, currently evades reliable detection, leaving women no choice for diagnosis other than invasive surgery. If these results are confirmed in larger Phase III studies, imaging with maraciclatide could transform clinical research and practice and potentially empower the development of treatments for women across the globe.
– Senior co-author, Professor Krina Zondervan, Co-Director of the Endometriosis CaRe Centre, Head of Department at the Nuffield Department of Women’s and Reproductive Health, and Co-theme Lead for the NIHR Oxford Biomedical Research Centre’s Surgical Innovation Theme
The completion and publication of this clinical study marks a pivotal achievement for Serac Healthcare. These data, derived from a representative patient population, including women receiving hormone therapy, provide evidence of maraciclatide's anticipated real-world performance. With FDA Fast Track Designation and agreed Phase III study designs, we are now advancing to validate these findings in larger trials and progress to regulatory submission.
– David Hail, CEO of Serac Healthcare
Outlook
The findings of this study could reduce the number of women undergoing unnecessary laparoscopic or thorascopic surgery while improving the accuracy and speed of diagnosis, as well as disease monitoring and management for millions of women across the world.
They also highlight the potential of nuclear imaging as a valuable tool in the diagnosis and management of endometriosis.
Further validation is required before this technique can be used in routine clinical practice. International multi-centre Phase III studies are due to begin later this year.
Novel, non-invasive diagnostic tests for endometriosis are a global research priority. The diagnostic challenge of endometriosis, which presents with varied and non-specific symptoms, is exacerbated by an absence of clinically validated biomarkers and the limitations of currently available imaging techniques. If these Phase II results are reproduced in the Phase III studies, maraciclatide has the potential to be an extremely valuable tool, as it could both reduce diagnostic delays and provide a validated endpoint for the development of new therapeutics.
– Professor Christian Becker, Co-Director of the Endometriosis CaRe Centre in Oxford, co-lead on the study and joint senior co-author on the paper
Contributions & Collaborations
The study was funded by the NIHR Oxford Biomedical Research Centre and Serac Healthcare Ltd, with scans performed at the Royal United Hospital, Bath.
The work was co-led by Professor Christian Becker, Professor Krina Zondervan, and Dr Tatjana Gibbons, at the Nuffield Department of Women's & Reproductive Health, University of Oxford.
Publication
- To view the publication, visit The Lancet
- Or download publication pdf: Assessment of endometriosis angiogenesis using ⁹⁹mTc-maraciclatide imaging (DETECT): a single-centre, exploratory, open-label, non-randomised, phase 2 study
For further information
Rob Phillips, Communications, Nuffield Department of Women's & Reproductive Health: +44 (0)7730 527341 rob.phillips@wrh.ox.ac.uk