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Blood Vessel Patterns in Small Choroidal Tumors

10. oktober 2022 opdateret af: Alison Skalet, OHSU Knight Cancer Institute

Characterization of Small Choroidal Tumors Using Functional Optical Coherence Tomography

The purpose of this study is to see if mapping blood vessel patterns with optical coherence tomography (OCT) will help identify life-threatening choroidal tumors in their early stages and improve overall patient survival through early detection.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Detaljeret beskrivelse

Uveal melanomas are melanocytic tumors that arise in the pigmented tissues of the eye: the iris, ciliary body, and choroid. Iris melanomas rarely metastasize (spread to other tissues or organs). In contrast, uveal melanomas arising in the ciliary body and choroid are highly malignant (cancerous and invasive to other tissues or organs). Despite having excellent local tumor control rates, uveal melanoma remains a life-threatening cancer, and even eye-sparing therapy with radiation treatment often leads to significant loss of vision. Therefore patients diagnosed with uveal melanoma must cope with not only a life-threatening illness, but also the frightening prospect of significant vision loss. Choroidal melanomas located in the posterior pole, an anatomical area of the eye which includes the optic nerve and macula (central retina), are of particular concern with regards to visual outcome, as radiation treatment to these areas for even the smallest of tumors is often associated with severe vision loss. The accurate diagnosis and treatment of small choroidal melanomas is critical to patient survival. When tumors with metastatic potential are recognized and treated at an early stage, survival prognosis improves dramatically.

The purpose of this study is to learn if malignant (life-threatening) choroidal tumors versus benign (non-life-threatening) tumors will show distinct blood vessel patterns using functional optical coherence tomography (OCT) angiography. Angiography is the mapping of blood vessels. The investigators believe that OCT angiography can provide data which may help in identifying life-threatening tumors at the earliest stages and improve overall survival for patients with this type of melanoma.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

15

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Oregon
      • Portland, Oregon, Forenede Stater, 97239
        • OHSU Knight Cancer Institute

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

This study will measure blood vessel pattern/flow changes in 15 patients with small posterior choroidal tumors.

Beskrivelse

Inclusion Criteria:

  • Adults older than age 18 with small (< 3mm) choroidal tumors located within the posterior pole region which can be imaged using OCT technology. Subjects with benign-appearing and malignant-appearing lesions meeting these criteria will be enrolled.

Exclusion Criteria:

  • Inability to give informed consent.
  • Inability to maintain stable fixation for OCT imaging.
  • Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
  • A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control).
  • Blood pressure > 180/110 (systolic above 180 OR diastolic above 110). If blood pressure is brought below 180/110 by anti-hypertensive treatment, subject can become eligible.
  • Women who are pregnant or lactating at the time of enrollment due to unknown safety of fluorescein angiography. Women that become pregnant during the course of the study may remain enrolled; however, flurorescein and ICG angiography will not be performed until they are no longer pregnant or nursing an infant.
  • Patients receiving treatment for uveal melanomas will be excluded from the longitudinal natural history portion of this study, but may enroll for a single study visit prior to treatment of their melanoma. They will then be eligible to enroll in IRB 9501, which will follow radiation-treated patients longitudinally.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Choroidal Tumor Group
15 patients diagnosed with small posterior choroidal tumors will be considered and evaluated for enrollment into this study

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Blood vessel patterns in small choroidal tumors
Tidsramme: 24 months
To determine if identifying early changes in blood vessel patterns will aid in early diagnosis and treatment of potentially aggressive choroidal tumors. This will be assessed using functional OCT angiography technology.
24 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

OHSU Knight Cancer Institute

Efterforskere

  • Ledende efterforsker: Alilson Skalet, MD, PhD, OHSU Knight Cancer Institute

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. oktober 2013

Primær færdiggørelse (Faktiske)

1. april 2015

Studieafslutning (Forventet)

1. december 2023

Datoer for studieregistrering

Først indsendt

30. september 2013

Først indsendt, der opfyldte QC-kriterier

7. oktober 2013

Først opslået (Skøn)

8. oktober 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. oktober 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. oktober 2022

Sidst verificeret

1. oktober 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IRB00009475
  • IRB#00009475 (Anden identifikator: OHSU Institutional Review Board)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Small Posterior Choroidal Tumors

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Sponsorer og samarbejdspartnere

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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