Ultrasound-guided Tru-Cut Biopsy in Pelvic Masses.

NCT05610501 | Recruiting

• 1 other identifier: S64793
• Study Type: observational
• Target: 200
• Locations: 4 countries
• Sites: 4

Brief Summary

In a transvaginal tru-cut biopsy, guided by ultrasound, a needle is inserted through the vaginal wall into a pelvic lesion and a few pieces of tissue are obtained for examination. This clinical trial is organized to evaluate the safety and efficacy of transvaginal tru-cut biopsy in a large group of patients with tumors in the small pelvis.

Conditions

Pelvic Cancer; Ovarian Cancer; Cervical Cancer; Uterus Cancer; Endometrial Cancer; Ovarian Neoplasms; Ovarian Carcinoma; Sarcoma Uterus; Metastatic Cancer

Keywords

Tru-cut; Ultrasound; Pelvic mass; Ovarian cancer; Gynaecologic oncology

Outcome Measures

Primary Outcomes (2)

• Safety

  Defined as absence of procedure-related complications. Procedure related complications will be graded by Clavien-Dindo classification.

  6 weeks

• Tissue yield

  Defined as sufficient amount of tissue for histological analysis. This will be a binary variable based on the pathology report.

  6 weeks after procedure

Secondary Outcomes (8)

• Factor 1 affecting safety and tissue yield

  6 weeks

• Factor 2 affecting safety and tissue yield

  6 weeks

• Factor 3 affecting safety and tissue yield

  6 weeks

• Factor 4 affecting safety and tissue yield

  6 weeks

• Factor 5 affecting safety and tissue yield

  6 weeks

Study Arms (1)

Patient population

All consecutive patients (\> 18 years) undergoing a tru-cut biopsy at the participating centers during the study periof will be eligible for inclusion in the study. All biopsies will be performed by trained operators in gynecologic ultrasound and tru-cut biopsies. Tissue samples will be assessed by experienced pathologists, dedicated in gynecologic oncology. Data will be collected by reviewing patients' electronic medical file including data concerning further treatment-strategy and pathology reports. Patients' level of pain and overall experience will be assessed by an independent investigator not present during biopsy. This will be performed from 0-72h after the biopsy using a numeric rating scale (0-100). Safety and complication-rate will be assessed by both using the collected data and via postprocedural assessment and by phone after six weeks. Inclusion and exclusion criteria can be found elsewhere.

Procedure: Ultrasound guided tru-cut biopsy

Interventions

Ultrasound guided tru-cut biopsy PROCEDURE

Tru-cut biopsies can collect tissue specimens via a needle of 18G A tru-cut biopsy can be performed under the guidance of different imaging modalities including ultrasound

Patient population

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients (\> 18 years) undergoing a tru-cut biopsy at the collaborating centers for a pelvic mass.

You may qualify if:

• \. Following lesion criteria applicable for biopsy:
• Lesion safely accessible (no visceral or vessel interposition; in the case of a transvaginal approach no vaginal stenosis (severe atrophy - virgo - vaginismus); within reach of biopsy needle)
• Solid component present (purely cystic lesions excluded)
• \. Biopsy for research purposes, the following is applicable: Patients with a gynecological tumor eligible for participation in academic or commercial clinical trials requesting a biopsy for translational research. For the current study, which is observational, we do not intend to take additional biopsies outside routine clinical practice, but only biopsies requested for participation in other (interventional) studies on systemic treatment in gynecologic oncology.
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• Suspicious primary disseminated gynecologic tumor (tumor itself or metastasis) Patients with a presumable new diagnosis of a disseminated pelvic tumor where histological confirmation of disease is necessary before the possibility to start a specific oncologic treatment and
• Are invalid candidates for primary (radical) surgery due to comorbidities or poor overall general wellbeing
• Are invalid candidates for primary (radical) surgery due to the extensive disease-spread according to imaging and/or diagnostic laparoscopy
• Suspicious primary disseminated NON-gynecologic tumor (tumor itself or metastasis)
• Patients with possible recurrence of a gynecological tumor (cervix, myometrial, endometrial, ovarian etc), where histological confirmation of disease recurrence is necessary before the possibility to start a surgical or systemic intervention.
• Patients with possible recurrence of a presumably non-gynecological tumor, where histological confirmation of disease recurrence is necessary before start of treatment.
• Solitary tumor of unknown histology localized in vaginal wall, parametria, retroperitoneum or uterine wall and can be punctured without spilling in abdominal cavity.

You may not qualify if:

• \- 1. Patients \< 18 years 2. Clotting defect or anticoagulation therapy, precluding a safe biopsy even with adapted therapy regimen.
• \. Vaginal or pelvic infection 4. Poor performance status contraindicating any specific oncologic treatment

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• UZ Leuven, Leuven, Belgium: collaborator
• Policlinico Universitario A. Gemelli, IRCSS, Rome, Italy.: collaborator
• Charles University, Czech Republic: collaborator
• Karolinska Institutet and Department of Obstetrics and Gynecology, Södersjukhuset, Stockholm, Sweden.: collaborator

Study Sites (4)

UZ Leuven

Leuven, Belgium

RECRUITING

First Faculty of Medicine, Charles University

Prague, Czechia

NOT YET RECRUITING

Fondazione Policlinico Universitario A. Gemelli, IRCSS

Rome, Italy

NOT YET RECRUITING

Department of Clinical Science and Education, Karolinska Institutet and Department of Obstetrics and Gynecology, Södersjukhuset

Stockholm, Sweden

NOT YET RECRUITING

Related Publications (25)

• Chandra A, Pius C, Nabeel M, Nair M, Vishwanatha JK, Ahmad S, Basha R. Ovarian cancer: Current status and strategies for improving therapeutic outcomes. Cancer Med. 2019 Nov;8(16):7018-7031. doi: 10.1002/cam4.2560. Epub 2019 Sep 27.

  PMID: 31560828 BACKGROUND

• Van Calster B, Van Hoorde K, Valentin L, Testa AC, Fischerova D, Van Holsbeke C, Savelli L, Franchi D, Epstein E, Kaijser J, Van Belle V, Czekierdowski A, Guerriero S, Fruscio R, Lanzani C, Scala F, Bourne T, Timmerman D; International Ovarian Tumour Analysis Group. Evaluating the risk of ovarian cancer before surgery using the ADNEX model to differentiate between benign, borderline, early and advanced stage invasive, and secondary metastatic tumours: prospective multicentre diagnostic study. BMJ. 2014 Oct 15;349:g5920. doi: 10.1136/bmj.g5920.

  PMID: 25320247 BACKGROUND

• Testa AC, Ferrandina G, Timmerman D, Savelli L, Ludovisi M, Van Holsbeke C, Malaggese M, Scambia G, Valentin L. Imaging in gynecological disease (1): ultrasound features of metastases in the ovaries differ depending on the origin of the primary tumor. Ultrasound Obstet Gynecol. 2007 May;29(5):505-11. doi: 10.1002/uog.4020.

  PMID: 17444565 BACKGROUND

• Epstein E, Van Calster B, Timmerman D, Nikman S. Subjective ultrasound assessment, the ADNEX model and ultrasound-guided tru-cut biopsy to differentiate disseminated primary ovarian cancer from metastatic non-ovarian cancer. Ultrasound Obstet Gynecol. 2016 Jan;47(1):110-6. doi: 10.1002/uog.14892.

  PMID: 25925783 BACKGROUND

• Vergote I, Trope CG, Amant F, Kristensen GB, Ehlen T, Johnson N, Verheijen RH, van der Burg ME, Lacave AJ, Panici PB, Kenter GG, Casado A, Mendiola C, Coens C, Verleye L, Stuart GC, Pecorelli S, Reed NS; European Organization for Research and Treatment of Cancer-Gynaecological Cancer Group; NCIC Clinical Trials Group. Neoadjuvant chemotherapy or primary surgery in stage IIIC or IV ovarian cancer. N Engl J Med. 2010 Sep 2;363(10):943-53. doi: 10.1056/NEJMoa0908806.

  PMID: 20818904 BACKGROUND

• Peiretti M, Zapardiel I, Zanagnolo V, Landoni F, Morrow CP, Maggioni A. Management of recurrent cervical cancer: a review of the literature. Surg Oncol. 2012 Jun;21(2):e59-66. doi: 10.1016/j.suronc.2011.12.008. Epub 2012 Jan 14.

  PMID: 22244884 BACKGROUND

• Al Rawahi T, Lopes AD, Bristow RE, Bryant A, Elattar A, Chattopadhyay S, Galaal K. Surgical cytoreduction for recurrent epithelial ovarian cancer. Cochrane Database Syst Rev. 2013 Feb 28;2013(2):CD008765. doi: 10.1002/14651858.CD008765.pub3.

  PMID: 23450588 BACKGROUND

• Bradford LS, Rauh-Hain JA, Schorge J, Birrer MJ, Dizon DS. Advances in the management of recurrent endometrial cancer. Am J Clin Oncol. 2015 Apr;38(2):206-12. doi: 10.1097/COC.0b013e31829a2974.

  PMID: 23764681 BACKGROUND

• Van Calster B, Van Hoorde K, Froyman W, Kaijser J, Wynants L, Landolfo C, Anthoulakis C, Vergote I, Bourne T, Timmerman D. Practical guidance for applying the ADNEX model from the IOTA group to discriminate between different subtypes of adnexal tumors. Facts Views Vis Obgyn. 2015;7(1):32-41.

  PMID: 25897370 BACKGROUND

• Agnes A, Biondi A, Ricci R, Gallotta V, D'Ugo D, Persiani R. Krukenberg tumors: Seed, route and soil. Surg Oncol. 2017 Dec;26(4):438-445. doi: 10.1016/j.suronc.2017.09.001. Epub 2017 Sep 12.

  PMID: 29113663 BACKGROUND

• Martinez A, Querleu D, Leblanc E, Narducci F, Ferron G. Low incidence of port-site metastases after laparoscopic staging of uterine cancer. Gynecol Oncol. 2010 Aug 1;118(2):145-50. doi: 10.1016/j.ygyno.2010.03.011. Epub 2010 May 7.

  PMID: 20451983 BACKGROUND

• Vergote I, Marquette S, Amant F, Berteloot P, Neven P. Port-site metastases after open laparoscopy: a study in 173 patients with advanced ovarian carcinoma. Int J Gynecol Cancer. 2005 Sep-Oct;15(5):776-9. doi: 10.1111/j.1525-1438.2005.00135.x.

  PMID: 16174223 BACKGROUND

• Heitz F, Ognjenovic D, Harter P, Kommoss S, Ewald-Riegler N, Haberstroh M, Gomez R, Barinoff J, Traut A, du Bois A. Abdominal wall metastases in patients with ovarian cancer after laparoscopic surgery: incidence, risk factors, and complications. Int J Gynecol Cancer. 2010 Jan;20(1):41-6. doi: 10.1111/IGC.0b013e3181c443ba.

  PMID: 20057285 BACKGROUND

• Malmstrom H. Fine-needle aspiration cytology versus core biopsies in the evaluation of recurrent gynecologic malignancies. Gynecol Oncol. 1997 Apr;65(1):69-73. doi: 10.1006/gyno.1996.4606.

  PMID: 9103393 BACKGROUND

• Chojniak R, Isberner RK, Viana LM, Yu LS, Aita AA, Soares FA. Computed tomography guided needle biopsy: experience from 1,300 procedures. Sao Paulo Med J. 2006 Jan 5;124(1):10-4. doi: 10.1590/s1516-31802006000100003. Epub 2006 Apr 3.

  PMID: 16612456 BACKGROUND

• Fischerova D, Cibula D, Dundr P, Zikan M, Calda P, Freitag P, Slama J. Ultrasound-guided tru-cut biopsy in the management of advanced abdomino-pelvic tumors. Int J Gynecol Cancer. 2008 Jul-Aug;18(4):833-7. doi: 10.1111/j.1525-1438.2007.01015.x. Epub 2007 Aug 30.

  PMID: 17764453 BACKGROUND

• Gupta S, Nguyen HL, Morello FA Jr, Ahrar K, Wallace MJ, Madoff DC, Murthy R, Hicks ME. Various approaches for CT-guided percutaneous biopsy of deep pelvic lesions: anatomic and technical considerations. Radiographics. 2004 Jan-Feb;24(1):175-89. doi: 10.1148/rg.241035063.

  PMID: 14730045 BACKGROUND

• Volpi E, Zola P, De Grandis T, Rumore A, Volpe T, Sismondi P. Transvaginal sonography in the diagnosis of pelvic malignant recurrence: integration of sonography and needle-guided biopsy. Ultrasound Obstet Gynecol. 1994 Mar 1;4(2):135-8. doi: 10.1046/j.1469-0705.1994.04020135.x.

  PMID: 12797207 BACKGROUND

• Sheth SS, Angirish J. Transvaginal trucut biopsy in patients with abdominopelvic mass. Int J Gynaecol Obstet. 1995 Jul;50(1):27-31. doi: 10.1016/0020-7292(95)02433-d.

  PMID: 7556856 BACKGROUND

• Faulkner RL, Mohiyiddeen L, McVey R, Kitchener HC. Transvaginal biopsy in the diagnosis of ovarian cancer. BJOG. 2005 Jul;112(7):991-3. doi: 10.1111/j.1471-0528.2005.00619.x.

  PMID: 15958006 BACKGROUND

• Zikan M, Fischerova D, Pinkavova I, Dundr P, Cibula D. Ultrasound-guided tru-cut biopsy of abdominal and pelvic tumors in gynecology. Ultrasound Obstet Gynecol. 2010 Dec;36(6):767-72. doi: 10.1002/uog.8803.

  PMID: 20737454 BACKGROUND

• Kong TW, Chang SJ, Paek J, Cho H, Lee Y, Lee EJ, Ryu HS. Transvaginal Sonography-Guided Core Biopsy of Adnexal Masses as a Useful Diagnostic Alternative Replacing Cytologic Examination or Laparoscopy in Advanced Ovarian Cancer Patients. Int J Gynecol Cancer. 2016 Jul;26(6):1041-7. doi: 10.1097/IGC.0000000000000728.

  PMID: 27206281 BACKGROUND

• Park JJ, Kim CK, Park BK. Ultrasound-Guided Transvaginal Core Biopsy of Pelvic Masses: Feasibility, Safety, and Short-Term Follow-Up. AJR Am J Roentgenol. 2016 Apr;206(4):877-82. doi: 10.2214/AJR.15.15702. Epub 2016 Feb 25.

  PMID: 26913556 BACKGROUND

• Zahedi R, Uppal S, Mendiratta-Lala M, Higgins EJ, Nettles AN, Maturen KE. Percutaneous image-guided pelvic procedures in women with gynecologic cancers: utilization, complications, and impact on patient management. Abdom Radiol (NY). 2016 Dec;41(12):2460-2465. doi: 10.1007/s00261-016-0882-9.

  PMID: 27565659 BACKGROUND

• Lin SY, Xiong YH, Yun M, Liu LZ, Zheng W, Lin X, Pei XQ, Li AH. Transvaginal Ultrasound-Guided Core Needle Biopsy of Pelvic Masses. J Ultrasound Med. 2018 Feb;37(2):453-461. doi: 10.1002/jum.14356. Epub 2017 Sep 8.

  PMID: 28885718 BACKGROUND

MeSH Terms

Conditions

Pelvic Neoplasms; Ovarian Neoplasms; Uterine Cervical Neoplasms; Uterine Neoplasms; Endometrial Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Cervical Diseases; Uterine Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Wouter Froyman, MD, PHD

CONTACT

+3216344202; wouter.froyman@uzleuven.be

Stefan Timmerman, MD

CONTACT

stefan.timmerman@uzleuven.be

Study Design

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

Study Record Dates

• First Submitted: September 28, 2022
• First Posted: November 9, 2022
• Study Start: May 1, 2021
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1); IT (1); BE (1); CZ (1)