The data was presented in a poster by Dr Tatjana Gibbons, an investigator on the study from the University of Oxford, at the 7th European Endometriosis Congress taking place from 6-8 June 2024 in Bucharest, Romania.
The poster available here builds on data previously presented in March and provides a summary of the first 10 patients in the DETECT study with known or suspected endometriosis who were imaged with a SPECT-CT camera and subsequently underwent planned laparoscopic surgery, a key-hole surgical procedure to establish the presence, absence and location of endometriotic lesions.
The imaging findings were compared to the surgical and histology reports and indicate that 99mTc-maraciclatide has potential as a non-invasive test for early-stage endometriosis. The poster provides summary information on the patient populations and the numbers of lesions identified by imaging.
findings include:
- 99mTc-maraciclatide correctly identified superficial peritoneal endometriosis in those who went on to have this early-stage endometriosis confirmed by laparoscopy.
- Superficial peritoneal endometriosis which is found in the thin peritoneum lining which covers the abdomen and pelvis, was the most common visualised lesion. Currently these can only be identified accurately by surgery and this subtype accounts for c. 80% of all endometriosis diagnoses.
- Deep disease and endometrioma were also identified by 99mTc-maraciclatide and correlated with findings from laparoscopy.
The poster concludes that visualising angiogenic integrins could aid in the non-invasive detection of endometriosis and could help address the challenges of detecting superficial disease.
The ongoing study which will recruit up to 25 patients in total is being led by Professor Christian Becker, Co-Director of the Endometriosis CaRe Centre in Oxford, together with Professor Krina Zondervan, Co-Director of the Endometriosis CaRe Centre and Head of Department at the Nuffield Department of Women’s and Reproductive Health, University of Oxford. It is anticipated that the study will complete later this year.
99mTc-maraciclatide is a radio-labelled tracer which binds with high affinity to the cell adhesion protein αvβ3 integrin and images angiogenesis (new blood vessel formation) which is known to be critical to the establishment and growth of endometriotic lesions.
Quotes
David Hail, Chief Executive Officer of Serac Healthcare, said:
“The promising initial findings have been further confirmed by more patients in this study, indicating the very exciting possibility that maraciclatide has potential as a non-invasive method of diagnosing early-stage endometriosis. This could dramatically reduce the average delay of nine years for a diagnosis, whilst also avoiding invasive surgery. We look forward to completing this study with the world-class team at Oxford University and we are now looking ahead to Phase III study design.”
Professor Christian Becker, Co-Director of the Endometriosis CaRe Centre at the University of Oxford added:
“A new diagnostic tool is urgently needed in this painful disease which often impacts fertility. These interim results are highly encouraging; we look forward to completing the study and the full analysis of its findings.”
Professor Krina Zondervan, Head of Department at the Nuffield Department of Women’s and Reproductive Health, University of Oxford and Co-Director of the Endometriosis CaRe Centre added:
“A non-invasive diagnostic option for superficial peritoneal endometriosis could be transformative in enabling young women to make different life choices and avoid years of pain. The team at the Endometriosis CaRe Centre is dedicated to improving the health and care of women suffering from endometriosis; maraciclatide has a real possibility of helping us to meet this goal.”
Maraciclatide is for investigational use only and is not approved by the FDA or UK and European regulatory authorities.
For more information, please contact:
David Hail, Chief Executive
Francetta Carr, Communications
francettacarr@seraclifesciences.com
Nuffield Department of Women’s and Reproductive Health, Oxford University
Rob Phillips, Communications
About Serac Healthcare Ltd
Serac Healthcare is a clinical radiopharmaceutical company with deep expertise in discovering, developing and commercialising innovative molecular imaging technologies. Using these targeted technologies to underpin personalised medicine in the fields of endometriosis and inflammatory arthritis, Serac Healthcare is focused on bringing to market effective tools to accelerate diagnosis, and to deliver earlier and more effective treatment decisions. Serac Healthcare Ltd is a wholly owned subsidiary of Serac Life Sciences Limited.
About Nuffield Department of Women's & Reproductive Health
The Nuffield Department of Women’s & Reproductive Health (NDWRH) at the University of Oxford is a pioneering institution with a rich legacy dating back to 1937; and stands as a vanguard of excellence in perinatal research and clinical practice.
Our vision is clear: a world where everyone enjoys high-quality, evidence-based women's and reproductive healthcare. Through cutting-edge research and transformative teaching, we're committed to elevating the standard and accessibility of women's healthcare worldwide.
For further information about NDWRH and its groundbreaking initiatives, please visit https://www.wrh.ox.ac.uk
About 99mTc-maraciclatide
99mTc-maraciclatide is a radio-labelled tracer which binds with high affinity to the cell adhesion protein αvβ3 integrin and images angiogenesis (new blood vessel formation). Clinical trials in a range of conditions, including breast cancer, bone metastases and rheumatoid arthritis, in which angiogenesis plays a key role, have shown the agent to perform as expected and be well tolerated. Angiogenesis is also known to be critical to the establishment and growth of endometriotic lesions.
About endometriosis
Endometriosis is a common inflammatory disease that affects up to one in 10 women of childbearing age, about 190 million women worldwide. Endometriosis occurs when tissue similar to the lining of the uterus is found outside the uterus, predominantly in the pelvis, but sometimes also elsewhere in the body, e.g. lungs. The presence of this ectopic endometrial tissue can lead to inflammation and distortion of normal anatomy, which can cause significant pain and infertility. The diagnostic journey in those with endometriosis typically results in numerous visits to physicians and hospitals, along with multiple scans.
About the DETECT study
The study is jointly sponsored by the Oxford Endometriosis CaRe Centre and the Nuffield Department of Women’s and Reproductive Health, Oxford University, and funded by Serac Healthcare Ltd who are providing the experimental imaging marker 99mTc-maraciclatide. Further details are available on ClinicalTrials.gov here.