New scan detects endometriosis without surgery in early trial
Study published in The Lancet Obstetrics, Gynaecology & Women’s Health finds experimental imaging agent could identify even the hardest-to-diagnose forms of the disease.
A new imaging technique could help detect endometriosis without the need for surgery, according to a study published in The Lancet Obstetrics, Gynaecology & Women’s Health.
Researchers, working with Serac Healthcare, found that the investigational imaging agent, 99mTc-maraciclatide, was able to visualise all major types of endometriosis in a small Phase 2 trial - including forms that are typically missed by standard scans.
“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,” said Dr Tatjana Gibbons, lead author of the study at the University of Oxford.
Delayed diagnosis
Endometriosis affects an estimated 190 million women worldwide, but diagnosis is often delayed by years. Current imaging methods such as ultrasound and MRI tend to detect structural changes associated with more advanced disease, meaning early-stage cases frequently go undetected and require laparoscopic surgery for confirmation.
The new approach works differently. Rather than looking for structural changes, instead maraciclatide detects angiogenesis - the formation of new blood vessels - an early biological process involved in the development of endometriosis.
This appears particularly significant for superficial peritoneal endometriosis (SPE), the most common form of the condition, found in around 80% of cases diagnosed via surgery. SPE is also one of the hardest forms to identify using existing imaging tools.
In the study, imaging results matched surgical findings in most participants, with no false positives reported. The technique also detected disease that had been missed by previous scans, including in patients who had undergone ultrasound or MRI within the past year.
“Novel, non-invasive diagnostic tests for endometriosis are a global research priority,” said Professor Christian Becker, co-director of the Endometriosis CaRe Centre in Oxford. “If these Phase II results are reproduced in Phase III studies, maraciclatide has the potential to be an extremely valuable tool.”
Researchers say the technology could have broader implications beyond diagnosis. A reliable, non-invasive way to detect and monitor endometriosis could make it easier to run clinical trials and assess whether treatments are working — a longstanding challenge in the field.
“Superficial peritoneal endometriosis… currently evades reliable detection, leaving women no choice for diagnosis other than invasive surgery,” said Professor Krina Zondervan, head of department at Oxford’s Nuffield Department of Women’s and Reproductive Health.
“If these results are confirmed… imaging with maraciclatide could transform clinical research and practice.”
Further plans
The Phase 2 trial involved 20 participants and was conducted at a single centre. Larger, international Phase 3 studies are expected to begin later this year to confirm the findings.
The imaging agent is still investigational and has not yet been approved by regulators, although it does have FDA fast track designation.
David Hail, CEO of Serac Healthcare, commented:
“The completion and publication of this clinical study is a major milestone for Serac Healthcare. These data, 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 3 study designs, we are now advancing to validate these findings in larger trials and progress to regulatory submission.”