Clinical trial · Interventional
Photoacoustic Endoscopy in Endometrial Cancer
A Pilot Study of Photoacoustic Endoscopy in Endometrial Cancer
NCT01498237CI-TRIAL-00011312withdrawnEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Need to obtain IDE prior to commencement of study
Summary
Brief summary (as posted)
The purpose of this research study is to evaluate whether a new technology called intrauterine photoacoustic endoscopy (PAE) can be used to evaluate the inner lining of the uterus.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Benign Neoplasm of Body of Uterus | Benign Uterine Corpus Neoplasm | ALIAS | 0.90 |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Photoacoustic endoprobe | Device | — | UNRESOLVED |
| Photoacoustic endoscopy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Photoacoustic endoscopy
- description
- This is a one-arm, feasibility study to determine how well the experimental procedure photoacoustic endoscopy will evaluate the human endometrial cavity in vivo.
- interventionNames
- Device: Photoacoustic endoprobe
- Procedure: Photoacoustic endoscopy
Primary outcomes (1)
- measure
- Feasibility of using the device to image endometrial cancer
- timeFrame
- 12 months or less
- description
- Feasibility of using this novel device to image endometrial cancer is our primary objective. The frequency of success in obtaining images, overall and per group, will be presented and binomial success rates with 95% confidence interval estimates will be calculated. Besides the overall success rates, graphical and tabular summaries of the feasibility across patient demographic and clinical characteristics will be created.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women diagnosed with benign gynecologic pathology (N=10) or biopsy proven endometrial cancer (N=10) who will undergo hysterectomy. * Participants must be ≥ 18 years of age. * Subjects of reproductive potential must have a negative pregnancy test prior to study photoacoustic endoscopy procedure and hysterectomy. * Subjects must be able understand and willing to sign a written informed consent form. Exclusion Criteria: * Subjects with contraindications for general anesthesia or hysterectomy. * Subjects with evidence of active pelvic inflammatory disease or purulent cervicitis. * Subjects with prior endometrial ablation procedures. * Gross tumoral involvement of the cervix or lower genital tract precluding cervical dilatation and endometrial sounding.
References
Publications (32)
- BACKGROUNDMorrow CP, Bundy BN, Kurman RJ, Creasman WT, Heller P, Homesley HD, Graham JE. Relationship between surgical-pathological risk factors and outcome in clinical stage I and II carcinoma of the endometrium: a Gynecologic Oncology Group study. Gynecol Oncol. 1991 Jan;40(1):55-65. doi: 10.1016/0090-8258(91)90086-k. PMID 1989916
- BACKGROUNDKilgore LC, Partridge EE, Alvarez RD, Austin JM, Shingleton HM, Noojin F 3rd, Conner W. Adenocarcinoma of the endometrium: survival comparisons of patients with and without pelvic node sampling. Gynecol Oncol. 1995 Jan;56(1):29-33. doi: 10.1006/gyno.1995.1005. PMID 7821843
- BACKGROUNDCragun JM, Havrilesky LJ, Calingaert B, Synan I, Secord AA, Soper JT, Clarke-Pearson DL, Berchuck A. Retrospective analysis of selective lymphadenectomy in apparent early-stage endometrial cancer. J Clin Oncol. 2005 Jun 1;23(16):3668-75. doi: 10.1200/JCO.2005.04.144. Epub 2005 Feb 28. PMID 15738538
- BACKGROUNDChan JK, Cheung MK, Huh WK, Osann K, Husain A, Teng NN, Kapp DS. Therapeutic role of lymph node resection in endometrioid corpus cancer: a study of 12,333 patients. Cancer. 2006 Oct 15;107(8):1823-30. doi: 10.1002/cncr.22185. PMID 16977653
- BACKGROUNDKeys HM, Roberts JA, Brunetto VL, Zaino RJ, Spirtos NM, Bloss JD, Pearlman A, Maiman MA, Bell JG; Gynecologic Oncology Group. A phase III trial of surgery with or without adjunctive external pelvic radiation therapy in intermediate risk endometrial adenocarcinoma: a Gynecologic Oncology Group study. Gynecol Oncol. 2004 Mar;92(3):744-51. doi: 10.1016/j.ygyno.2003.11.048. PMID 14984936
- BACKGROUNDJemal A, Siegel R, Ward E, Hao Y, Xu J, Thun MJ. Cancer statistics, 2009. CA Cancer J Clin. 2009 Jul-Aug;59(4):225-49. doi: 10.3322/caac.20006. Epub 2009 May 27. PMID 19474385
- BACKGROUNDASTEC study group; Kitchener H, Swart AM, Qian Q, Amos C, Parmar MK. Efficacy of systematic pelvic lymphadenectomy in endometrial cancer (MRC ASTEC trial): a randomised study. Lancet. 2009 Jan 10;373(9658):125-36. doi: 10.1016/S0140-6736(08)61766-3. Epub 2008 Dec 16.