Photoacoustic Endoscopy in Endometrial Cancer
9 juli 2013 bijgewerkt door: Washington University School of Medicine
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.
Studie Overzicht
Toestand
Ingetrokken
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Fase
- Vroege fase 1
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Vrouw
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Diagnostisch
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Photoacoustic endoscopy
This is a one-arm, feasibility study to determine how well the experimental procedure photoacoustic endoscopy will evaluate the human endometrial cavity in vivo.
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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.
Andere namen:
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.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Feasibility of using the device to image endometrial cancer
Tijdsspanne: 12 months or less
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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.
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12 months or less
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Israel Zighelboim, MD, Washington University School of Medicine
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
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Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 januari 2012
Primaire voltooiing (Verwacht)
1 december 2012
Studie voltooiing (Verwacht)
1 december 2012
Studieregistratiedata
Eerst ingediend
12 december 2011
Eerst ingediend dat voldeed aan de QC-criteria
22 december 2011
Eerst geplaatst (Schatting)
23 december 2011
Updates van studierecords
Laatste update geplaatst (Schatting)
11 juli 2013
Laatste update ingediend die voldeed aan QC-criteria
9 juli 2013
Laatst geverifieerd
1 juli 2013
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 201102405
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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