DETECT (Detecting Endometriosis inTEgrins Using teChneTium-99m Imaging Study)

NCT05623332 | Enrolling By Invitation DMC

• 1 other identifier: 16073
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Endometriosis is a common gynaecological disease affecting 10% of the female population due to the presence of uterus-like tissue outside of the uterus, often in the pelvis. The disease causes severe lower abdominal pain mostly during the monthly period, during or after sexual intercourse, and when emptying the bowel and bladder. Currently, imaging methods such as ultrasound are ineffective at diagnosing the most common type of endometriosis, pelvic endometriosis. Therefore, we are heavily reliant on invasive surgery to make the diagnosis. This study aims to investigate the presence of binding proteins (integrins) in endometriotic tissue which will expand our understanding of endometriosis and could be used as a target to develop a non-invasive imaging test in the future. Women with symptoms consistent with endometriosis, who are due to undergo surgery to diagnose endometriosis at the EndoCare Unit in Oxford, will be eligible to participate. To attempt to visualise the integrins, participants will be asked to attend 2-7 days before their surgery to undergo an imaging scan with a molecular marker that has been found to highlight integrins in other conditions. The possibility of machine learning enhancement of integrin expression will be tested. The findings on the scan will be compared to the findings at surgery. Samples during surgery of endometriosis tissues, the endometrium, and salty water that has been flushed through the uterus, will be analysed in the lab to look for differences in the amount of integrin present in women with and without endometriosis and whether factors such as the phase of the menstrual cycle or hormonal treatment effect the amount seen.

Conditions

Endometriosis

Keywords

non-invasive diagnosis; SPECT-CT

Outcome Measures

Primary Outcomes (1)

• The correlation between locations of maraciclatide uptake identified on SPECT-CT.(described qualitatively by a radiologist) and the locations of endometriotic lesions detected during laparoscopy (described qualitatively by a surgeon)

  To assess whether alpha-v-beta-3 lesions integrins can be detected in endometriotic lesions using Maraciclatide and SPECT-CT imaging.

  Single comparison, maraciclatide scan to precede laparoscopy (which will occur 2-7days later)

Secondary Outcomes (9)

• The single best timepoint described by two radiologists following the evaluation of SPECT-CT scans at multiple time points after injection of maraciclatide.

  Participants will undergo 1- 6 imaging scans at 30minutes, 90 minutes, 3-4 hours, 6 hours, or 18-24 hours post administration

• The single preference of two radiologists when assessing SPECT-CT images before and after machine learning-enhancement.

  Any time through the study completion, an average of 2 years

• The single preference of two radiologists when assessing SPECT-CT images with and without machine learning enhancement using ultrasound scans.

  All SPECT-CT images throughout study completion (average of 2 years) and any routine ultrasound images within 3 months of the scan.

• The difference in alpha-V beta-3 integrin expression (using immunofluorescence) in endometrial biopsies from women with and without endometriosis.

  Any time through the study completion, an average of 2 years

• The difference in alpha-V beta-3 integrin expression (using ELISA) in endometrial flushes from women with and without endometriosis.

  Any time through the study completion, an average of 2 years

Study Arms (2)

Maraciclatide imaging group

Women referred to the endometriosis clinic for suspected endometriosis undergoing a maraciclatide imaging scan

Diagnostic Test: Maraciclatide

Control

Control group (samples but no scan) - Women undergoing surgery for any other condition than endometriosis

Interventions

Maraciclatide DIAGNOSTIC_TEST

Imaging marker that binds to AVB3/5 lesions

Maraciclatide imaging group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Born female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women suspected of endometriosis due to have a diagnostic/therapeutic laparoscopy

You may qualify if:

• Participant is willing and able to give informed consent for participation in the study.
• Female aged 18 years or above.
• Symptoms consistent with endometriosis and therefore due to undergo a laparoscopy for diagnostic (+/- therapeutic) purposes.
• Willing and able to comply with scheduled visits.
• In the Investigator's opinion, is able and willing to comply with all study requirements.
• Women enrolling for the tissue sample comparison group: Women undergoing planned surgery (including hysterectomy) for gynaecological disease except endometriosis e.g., fibroid-associated symptoms such as abdominal pain, abnormal uterine bleeding, fertility investigation or for laparoscopic tubal sterilisation.

You may not qualify if:

• Female participant who is pregnant, lactating or planning pregnancy during the study.
• Known significant renal or hepatic impairment (E.g., eGFR \<50ml/min/1.73m2 on recent blood tests).
• Any significant disease or disorder such as gynaecological cancers, in the opinion of the Investigator, may either put the participants at risk because of participation in the study or may influence the result of the study.
• High dose intravenous or intramuscular steroid in the past 12 weeks.
• Participants with a known allergy to technetium.
• Participants who have recently participated in another research study, in the opinion of the investigator will affect the results of the project.

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

John Radcliffe Hospital

Oxford, OXON, OX3 9DU, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Ectopic endometriosis lesions samples, endometrial samples, and endometrial flush

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2022
• First Posted: November 21, 2022
• Study Start: March 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: October 1, 2024
• Last Updated: June 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)