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Endometrial CancerEarly Phase 1NCT01498237

Photoacoustic Endoscopy in Endometrial Cancer

A Early Phase 1 study testing Photoacoustic endoprobe and Photoacoustic endoscopy in people with Endometrial Cancer and Benign Neoplasm of Body of Uterus, run by Washington University School of Medicine.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Photoacoustic endoprobe and Photoacoustic endoscopy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jan 2012to Dec 2012
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

About this study

Official title: A Pilot Study of Photoacoustic Endoscopy in Endometrial Cancer

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.

Read the detailed description

The investigators will evaluate whether this technology can be used and also try to obtain photoacoustic images and functional data (oxygen contents, blood vessel characteristics, etc) of the uterine lining to assess its appearance in women with and without cancer of the endometrium. Currently, it is difficult for physicians to know whether or not tumors of the endometrium have invaded and spread to other organs without performing an extended surgery called a staging operation (removal of the lymph nodes or glands that drain the uterus to assess under the microscope whether or not the cancer has spread). Our long term goal is to use this new photoacoustic (PA) technology to improve detection of occult metastatic disease. Occult disease is defined as tumor which cannot be seen without the use of imaging techniques. and possibly avoid the need of extended operations. All of this could result in better care for patients with endometrial cancer and other gynecologic problems.

Being tested
Photoacoustic endoprobe, Photoacoustic endoscopy
Keywords
Photoacoustic endoscopy
Medical subject headings
Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Photoacoustic endoprobeDevice

    Also called There are no other interventions.

    The PAE assessment will be performed in the operating room following strict sterile technique. PAE is performed immediately prior to the planned surgery. Participants are prepped following standard protocol. Length of the endometrial cavity is determined by a uterine sound. Endocervix is dilated as needed to allow passage of the PAE probe. The PAE probe will be advanced to the uterine fundus. Images will be obtained during withdrawal of the PAE probe from fundus to the os. Recorded images will allow computer assisted image analysis and functional measurements to be performed. Duration and difficulty of the procedure will be recorded. Comments and complications will be specifically noted.

  • Photoacoustic endoscopyProcedure or surgery

    Also called There are no other interventions.

    Photoacoustic endoscopy probe will be inserted into the endometrial canal to the uterine fundus and images will be obtained during the withdrawal of the probe from the fundus to the endocervical os.

Study groups in NCT01498237
Study groupRoleWhat they receive
Photoacoustic endoscopyExperimentalThis is a one-arm, feasibility study to determine how well the experimental procedure photoacoustic endoscopy will evaluate the human endometrial cavity in vivo.
Receives: Device: Photoacoustic endoprobe; Procedure: Photoacoustic endoscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of using the device to image endometrial cancer

    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.

    Measured: 12 months or less

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2011 (estimated)
  2. Study startJan 2012
  3. Primary completionDec 2012 (estimated)
  4. Study completionDec 2012 (estimated)

Why it stopped: Need to obtain IDE prior to commencement of study

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01498237
Sponsor's protocol ID
201102405
Status last verified
Jul 2013
First submitted
12 Dec 2011
Last updated
11 Jul 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Morrow 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.

    PubMed 1989916

  • Kilgore 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.

    PubMed 7821843

  • Cragun 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.

    PubMed 15738538

  • Chan 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.

    PubMed 16977653

  • Keys 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.

    PubMed 14984936

  • Jemal 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.

    PubMed 19474385

  • ASTEC 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.

    PubMed 19070889

  • Benedetti Panici P, Basile S, Maneschi F, Alberto Lissoni A, Signorelli M, Scambia G, Angioli R, Tateo S, Mangili G, Katsaros D, Garozzo G, Campagnutta E, Donadello N, Greggi S, Melpignano M, Raspagliesi F, Ragni N, Cormio G, Grassi R, Franchi M, Giannarelli D, Fossati R, Torri V, Amoroso M, Croce C, Mangioni C. Systematic pelvic lymphadenectomy vs. no lymphadenectomy in early-stage endometrial carcinoma: randomized clinical trial. J Natl Cancer Inst. 2008 Dec 3;100(23):1707-16. doi: 10.1093/jnci/djn397. Epub 2008 Nov 25.

    PubMed 19033573

  • ASTEC/EN.5 Study Group; Blake P, Swart AM, Orton J, Kitchener H, Whelan T, Lukka H, Eisenhauer E, Bacon M, Tu D, Parmar MK, Amos C, Murray C, Qian W. Adjuvant external beam radiotherapy in the treatment of endometrial cancer (MRC ASTEC and NCIC CTG EN.5 randomised trials): pooled trial results, systematic review, and meta-analysis. Lancet. 2009 Jan 10;373(9658):137-46. doi: 10.1016/S0140-6736(08)61767-5. Epub 2008 Dec 16.

    PubMed 19070891

  • Creasman W. Revised FIGO staging for carcinoma of the endometrium. Int J Gynaecol Obstet. 2009 May;105(2):109. doi: 10.1016/j.ijgo.2009.02.010. Epub 2009 Apr 3. No abstract available.

    PubMed 19345353

  • Zerbe MJ, Bristow R, Grumbine FC, Montz FJ. Inability of preoperative computed tomography scans to accurately predict the extent of myometrial invasion and extracorporal spread in endometrial cancer. Gynecol Oncol. 2000 Jul;78(1):67-70. doi: 10.1006/gyno.2000.5820.

    PubMed 10873413

  • Connor JP, Andrews JI, Anderson B, Buller RE. Computed tomography in endometrial carcinoma. Obstet Gynecol. 2000 May;95(5):692-6. doi: 10.1016/s0029-7844(99)00626-2.

    PubMed 10775731

  • Hricak H, Rubinstein LV, Gherman GM, Karstaedt N. MR imaging evaluation of endometrial carcinoma: results of an NCI cooperative study. Radiology. 1991 Jun;179(3):829-32. doi: 10.1148/radiology.179.3.2028000.

    PubMed 2028000

  • Cabrita S, Rodrigues H, Abreu R, Martins M, Teixeira L, Marques C, Mota F, de Oliveira CF. Magnetic resonance imaging in the preoperative staging of endometrial carcinoma. Eur J Gynaecol Oncol. 2008;29(2):135-7.

    PubMed 18459546

  • Horowitz NS, Dehdashti F, Herzog TJ, Rader JS, Powell MA, Gibb RK, Grigsby PW, Siegel BA, Mutch DG. Prospective evaluation of FDG-PET for detecting pelvic and para-aortic lymph node metastasis in uterine corpus cancer. Gynecol Oncol. 2004 Dec;95(3):546-51. doi: 10.1016/j.ygyno.2004.08.009.

    PubMed 15581961

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Photoacoustic endoprobe and Photoacoustic endoscopy in people with Endometrial Cancer and Benign Neoplasm of Body of Uterus, run by Washington University School of Medicine.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 11 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of using the device to image endometrial cancer (time frame: 12 months or less). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01498237, which also lists 32 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2013.

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