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Evaluation of a Novel Infra-red Breast Imaging System for Risk Assessment in Women at High Risk for Breast Cancer.

3. september 2018 opdateret af: Real Imaging Ltd.

Evaluation of REAL IMAGING'S 3D Functional Metabolic Imaging and Risk Assessment ("3D MIRA") System in Women at High Risk for Breast Cancer

Three-dimensional functional Metabolic Imaging (3D MIRA) is a new infrared imaging technology using the Real Imager 4(RI4) developed by Real Imaging. This technology generates 3D metabolic maps and based on sophisticated machine learning technology, provides objective risk assessment for the presence of malignant tumor. The procedure is non-invasive, comfortable and does not involve ionizing radiation. Moreover, Real Imaging's 3D Functional MIRA is unaffected by breast density and is therefore ideal for evaluating patients with mammographically dense breasts.

The purpose of this clinical study is to assess the ability of this novel technology to detect clinically occult breast cancer in a cohort of women that are at high risk for breast cancer.

We hypothesize that the combination of screening mammography and metabolic screening (3D MIRA) will result in significantly higher breast cancer detection rates.

Studieoversigt

Status

Ukendt

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

236

Kontakter og lokationer

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

Studiesteder

  • Israel
      • Ramat-Gan, Israel, 5262000
        • The Chaim Sheba Medical Center at Tel-Hashomer

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

20 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Women who are determined to have high risk of breast cancer and who are screened biannually by existing screening modalities (mammography, ultrasound or MRI)

Beskrivelse

Inclusion Criteria:

  • Female
  • Woman has read, understood and signed the inform consent form
  • Age: 20 years and older
  • Women who are asymptomatic for breast cancer
  • Proven carriers of deleterious BRCA1 or BRCA2 mutations Or Women that were found to have a lifetime risk of developing breast cancer greater or equal to 20% based on Tyrer-Cuzick, Gail or Clause risk models
  • Women scheduled to undergo routine mammography and/or US or MRI screening

Exclusion Criteria:

  • Women who have had a mammography and/or ultrasound examination performed on the day of the study prior to MIRA scan
  • Women who had a lumpectomy surgery
  • Women who had undergone mastectomy and/or reconstruction
  • Women who have undergone any type of breast surgery throughout the 6 months preceding the study
  • Women who have had a breast biopsy performed throughout the 10 weeks preceding the study.
  • Women who have a fever on the day of the MIRA imaging
  • Women who are pregnant
  • Women who are breast-feeding
  • Women who had undergone breast reduction/augmentation

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
Women at high risk for breast cancer
Proven carriers of deleterious BRCA1 or BRCA2 mutations Or Women that were found to have a lifetime risk of developing breast cancer greater or equal to 20% based on Tyrer-Cuzick, Gail or Clause risk models.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Diagnostic accuracy of 3D MIRA as a breast imaging aid in women with a high risk of breast cancer
Tidsramme: up to 36 months
up to 36 months

Sekundære resultatmål

Resultatmål
Tidsramme
To test whether repetitive screening with 3D MIRA technology can provide information on the likelihood of developing breast cancer.
Tidsramme: up to 36 months
up to 36 months

Samarbejdspartnere og efterforskere

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

Sponsor

Real Imaging Ltd.

Efterforskere

  • Ledende efterforsker: Miri Sklair-Levy, MD, The Chaim Sheba Medical Center at Tel-Hashomer

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. april 2014

Primær færdiggørelse (Faktiske)

1. juli 2017

Studieafslutning (Forventet)

1. oktober 2018

Datoer for studieregistrering

Først indsendt

7. december 2013

Først indsendt, der opfyldte QC-kriterier

7. december 2013

Først opslået (Skøn)

11. december 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. september 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. september 2018

Sidst verificeret

1. september 2018

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 960-CSP-ISR_HighRiskMC_ILS1

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 .

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Sponsorer og samarbejdspartnere

Medicinske tilstande

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CROs by country

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner