Assessment of Integrin Expression in Endometriosis
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05623332 |
Recruitment Status :
Enrolling by invitation
First Posted : November 21, 2022
Last Update Posted : November 21, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
Condition or disease | Intervention/treatment |
---|---|
Endometriosis | Diagnostic Test: Maraciclatide |
Study Type : | Observational |
Estimated Enrollment : | 25 participants |
Observational Model: | Other |
Time Perspective: | Prospective |
Official Title: | A Study of the Integrin Expression in Endometriosis by Novel in Vivo and in Vitro Assessment |
Actual Study Start Date : | November 1, 2022 |
Estimated Primary Completion Date : | December 2023 |
Estimated Study Completion Date : | April 2024 |
Group/Cohort | Intervention/treatment |
---|---|
Maraciclatide imaging group
Women referred to the endometriosis clinic for suspected endometriosis undergoing a maraciclatide imaging scan
|
Diagnostic Test: Maraciclatide
Imaging marker that binds to AVB3/5 lesions |
Control
Control group (samples but no scan) - Women undergoing surgery for any other condition than endometriosis
|
- 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) [ Time Frame: Single comparison, maraciclatide scan to precede laparoscopy (which will occur 2-7days later) ]To assess whether alpha-v-beta-3 lesions integrins can be detected in endometriotic lesions using Maraciclatide and SPECT-CT imaging.
- The single best timepoint described by two radiologists following the evaluation of SPECT-CT scans at multiple time points after injection of maraciclatide. [ Time Frame: Participants will undergo 1- 6 imaging scans at 30minutes, 90 minutes, 3-4 hours, 6 hours, or 18-24 hours post administration ]To identify the optimum imaging time interval and method following administration of intravenous maraciclatide.
- The single preference of two radiologists when assessing SPECT-CT images before and after machine learning-enhancement. [ Time Frame: Any time through the study completion, an average of 2 years ]To assess whether machine learning enhanced the ability to detect alpha-V-beta-3 integrin expression and whether this should be developed in later phase studies.
- The single preference of two radiologists when assessing SPECT-CT images with and without machine learning enhancement using ultrasound scans. [ Time Frame: All SPECT-CT images throughout study completion (average of 2 years) and any routine ultrasound images within 3 months of the scan. ]To assess whether machine learning enhanced the ability to detect alpha-V-beta-3 integrin expression and whether this should be developed in later phase studies.
- The difference in alpha-V beta-3 integrin expression (using immunofluorescence) in endometrial biopsies from women with and without endometriosis. [ Time Frame: Any time through the study completion, an average of 2 years ]To assess the angiogenic propensity of endometrial tissue in women with endometriosis.
- The difference in alpha-V beta-3 integrin expression (using ELISA) in endometrial flushes from women with and without endometriosis. [ Time Frame: Any time through the study completion, an average of 2 years ]To assess the angiogenic propensity of endometrial tissue in women with endometriosis.
- The expression of alpha-V beta-3 integrin (using immunofluorescence) in the ectopic endometrial tissue samples. [ Time Frame: Any time through the study completion, an average of 2 years ]To assess whether the phase of the cycle, hormonal influence or lesion activity affects the level of expression.
- The most frequently reported highest and lowest preference for diagnostic technique presented as a percentage. [ Time Frame: Any time through the study completion, an average of 2 years ]A national survey released via patient advocacy organisations and to those participating in the imaging study to explore the experiences and preferences of diagnostic methods in individuals undergoing investigation for endometriosis.
- VAS satisfaction and acceptability rating (0 lowest - 100 highest) of participants who have undergone a SPECT-CT to detect alpha-v-beta-3 lesions in endometriotic tissue. [ Time Frame: Any time through the study completion, an average of 2 years ]To determine whether SPECT-CT is received positively or negatively by participants undergoing investigation for endometriosis.
- The number of respondents who have experienced a diagnostic delay and the number of those who think this delay has affected their life decisions. [ Time Frame: Any time through the study completion, an average of 2 years ]To determine whether a delay in diagnosing endometriosis influences life decisions such as family planning.
Biospecimen Retention: Samples Without DNA
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | Born female |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05623332
United Kingdom | |
John Radcliffe Hospital | |
Oxford, Oxon, United Kingdom, OX3 9DU |
Responsible Party: | University of Oxford |
ClinicalTrials.gov Identifier: | NCT05623332 |
Other Study ID Numbers: |
16073 |
First Posted: | November 21, 2022 Key Record Dates |
Last Update Posted: | November 21, 2022 |
Last Verified: | June 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
non-invasive diagnosis SPECT-CT |
Endometriosis Genital Diseases, Female Female Urogenital Diseases |
Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Genital Diseases |