Combining Ultrasound and Biomarkers to Diagnose Superficial Endometriosis

NCT05523284 | Enrolling By Invitation

• 1 other identifier: LRG - SPGENDO
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Endometriosis is a benign gynecological disease characterized by uterine-like cells growing outside the uterus, leading to pain, infertility, and inflammation. Endometriosis most commonly occurs in the forms of Superficial Endometriosis (SE), Deep Endometriosis and Ovarian Endometriosis (Endometrioma) (OE). Ultrasound diagnosis of DE and OE has become more reliable with advances in ultrasound technology, technique and expertise, leading to decreased diagnosis time for patients and allowing for better optimization of surgeries if required. SE, however, lacks any reliable non-invasive diagnosis methods. SE is the most common form of endometriosis and is defined as a disease that lines the peritoneum and is small and superficial in nature, leading to chronic inflammation, infertility, and pain. SE is difficult to visualize on ultrasound due to its size and alignment with tissue, requiring fluid to expand the pelvis and partially suspend these small lesions, allowing them to be diagnosed through ultrasound. Leonardi et al. observed that in some patients, a physiologic change occurs whereby fluid fills the pouch of Douglas (POD), allowing increased visualizing during ultrasound. This led to the development of Saline-infused sonoPODgraphy (SPG), a novel method utilizing modified commonly used ultrasound techniques called saline-infusion sonohysterography (SIS) and hysterosalpingo-contrast-sonography (HyCoSy), to reliably visualize the POD (Leonardi et al, 2019). Visualizing the POD is important as SE is often deposited in the POD. This diagnostic accuracy pilot study aims to pioneer the technique whereby SPG will be evaluated as a novel, rapid, non-invasive diagnostic tool for SE. The injected fluid from the POD will be withdrawn and evaluated for novel biomarkers, allowing us to further develop rapid diagnostics and better understand disease mechanisms. We hypothesize that SPG will allow for the diagnosis of SE with a diagnostic accuracy parallel to the current invasive gold standard, laparoscopy.

Conditions

Endometriosis (Diagnosis); Endometriosis

Keywords

Endometriosis; Diagnosis; Ultrasound; Biomarkers

Outcome Measures

Primary Outcomes (1)

• Determine the diagnostic accuracy of SPG as a non-invasive diagnostic modality for superficial endometriosis, in the absence of DE, OE, and POD obliteration.

  The diagnostic accuracy of SPG and biomarkers will be compared to the current gold standard, laparoscopy and histology.

  2022-2024

Secondary Outcomes (4)

• 1. Characterize superficial endometriosis under TVS using modified descriptors from the Leonardi et al (2020) SPG study.

  2022-2024

• 2. Determine the association between TVS and surgical characteristics of superficial endometriosis using the accepted World Endometriosis Research Foundation (WERF) guidelines

  2022-2024

• 3. Assess the tolerability and acceptance of SPG as a rapid, non-invasive diagnostic technique for SE among those with endometriosis using a questionnaire

  2022-2024

• 4. Externally validate the Determine the rate of success rate of SPG (fluid filling the POD) from a technicity perspective

  2022-2024

Interventions

SonoPODography DIAGNOSTIC_TEST

SonoPODography (SPG) is a novel ultrasound-guided technique whereby saline is injected through the cervix and flushed into the POD, creating an acoustic window for diagnosing superficial endometriosis.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All participants will be recruited from the McMaster Women's Health Clinic during routine pelvic evaluation using transvaginal ultrasound to assess the pelvic and abdominal cavity for any pathologies. Only participants with a uterus (assigned female at birth) will be eligible to join the study.

You may qualify if:

• Years of Age
• Assigned Female at Birth
• Confirmed or Suspected Case of Superficial Endometriosis
• Willing and Able to Provide Informed Written Consent

You may not qualify if:

• Pre-Menarche or Post-Menopausal
• No History of Vaginal Penetration / Intercourse
• Concern for pre-malignancy or presence/history of malignancy
• Known Bleeding Disorder
• Presence of Deep or Ovarian Endometriosis

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4L8, Canada

Location

Related Publications (12)

• Leonardi M, Robledo KP, Espada M, Vanza K, Condous G. SonoPODography: A new diagnostic technique for visualizing superficial endometriosis. Eur J Obstet Gynecol Reprod Biol. 2020 Nov;254:124-131. doi: 10.1016/j.ejogrb.2020.08.051. Epub 2020 Sep 16.

  PMID: 32961428 RESULT

• Chapron C, Tosti C, Marcellin L, Bourdon M, Lafay-Pillet MC, Millischer AE, Streuli I, Borghese B, Petraglia F, Santulli P. Relationship between the magnetic resonance imaging appearance of adenomyosis and endometriosis phenotypes. Hum Reprod. 2017 Jul 1;32(7):1393-1401. doi: 10.1093/humrep/dex088.

  PMID: 28510724 RESULT

• Cheong YC, Shelton JB, Laird SM, Richmond M, Kudesia G, Li TC, Ledger WL. IL-1, IL-6 and TNF-alpha concentrations in the peritoneal fluid of women with pelvic adhesions. Hum Reprod. 2002 Jan;17(1):69-75. doi: 10.1093/humrep/17.1.69.

  PMID: 11756364 RESULT

• Deslandes A, Parange N, Childs JT, Osborne B, Bezak E. Current Status of Transvaginal Ultrasound Accuracy in the Diagnosis of Deep Infiltrating Endometriosis Before Surgery: A Systematic Review of the Literature. J Ultrasound Med. 2020 Aug;39(8):1477-1490. doi: 10.1002/jum.15246. Epub 2020 Feb 21.

  PMID: 32083336 RESULT

• Forster R, Sarginson A, Velichkova A, Hogg C, Dorning A, Horne AW, Saunders PTK, Greaves E. Macrophage-derived insulin-like growth factor-1 is a key neurotrophic and nerve-sensitizing factor in pain associated with endometriosis. FASEB J. 2019 Oct;33(10):11210-11222. doi: 10.1096/fj.201900797R. Epub 2019 Jul 10.

  PMID: 31291762 RESULT

• Goncalves MO, Siufi Neto J, Andres MP, Siufi D, de Mattos LA, Abrao MS. Systematic evaluation of endometriosis by transvaginal ultrasound can accurately replace diagnostic laparoscopy, mainly for deep and ovarian endometriosis. Hum Reprod. 2021 May 17;36(6):1492-1500. doi: 10.1093/humrep/deab085.

  PMID: 33864088 RESULT

• Leonardi M, Espada M, Lu C, Stamatopoulos N, Condous G. A Novel Ultrasound Technique Called Saline Infusion SonoPODography to Visualize and Understand the Pouch of Douglas and Posterior Compartment Contents: A Feasibility Study. J Ultrasound Med. 2019 Dec;38(12):3301-3309. doi: 10.1002/jum.15022. Epub 2019 May 15.

  PMID: 31090229 RESULT

• Piessens S, Edwards A. Sonographic Evaluation for Endometriosis in Routine Pelvic Ultrasound. J Minim Invasive Gynecol. 2020 Feb;27(2):265-266. doi: 10.1016/j.jmig.2019.08.027. Epub 2019 Sep 4.

  PMID: 31493569 RESULT

• Reis FM, Santulli P, Marcellin L, Borghese B, Lafay-Pillet MC, Chapron C. Superficial Peritoneal Endometriosis: Clinical Characteristics of 203 Confirmed Cases and 1292 Endometriosis-Free Controls. Reprod Sci. 2020 Jan;27(1):309-315. doi: 10.1007/s43032-019-00028-1. Epub 2020 Jan 1.

  PMID: 32046376 RESULT

• Vercellini P, Vigano P, Somigliana E, Fedele L. Endometriosis: pathogenesis and treatment. Nat Rev Endocrinol. 2014 May;10(5):261-75. doi: 10.1038/nrendo.2013.255. Epub 2013 Dec 24.

  PMID: 24366116 RESULT

• Vitonis AF, Vincent K, Rahmioglu N, Fassbender A, Buck Louis GM, Hummelshoj L, Giudice LC, Stratton P, Adamson GD, Becker CM, Zondervan KT, Missmer SA; WERF EPHect Working Group. World Endometriosis Research Foundation Endometriosis Phenome and Biobanking Harmonization Project: II. Clinical and covariate phenotype data collection in endometriosis research. Fertil Steril. 2014 Nov;102(5):1223-32. doi: 10.1016/j.fertnstert.2014.07.1244. Epub 2014 Sep 22.

  PMID: 25256930 RESULT

• Zondervan KT, Becker CM, Missmer SA. Endometriosis. N Engl J Med. 2020 Mar 26;382(13):1244-1256. doi: 10.1056/NEJMra1810764. No abstract available.

  PMID: 32212520 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

SPG fluid (flushed saline) will be aspirated from the POD and evaluated using full proteomic and genomic analysis.

MeSH Terms

Conditions

Endometriosis; Disease

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: August 31, 2022
• Study Start: November 15, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 12, 2026

Record last verified: 2025-05

Locations

CA (1)