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Use of an In Vivo Optical Probe to Discriminate Benign From Malignant Thyroid Nodules

15. juni 2016 oppdatert av: Stephanie Lee, Boston Medical Center

Optical Probe In Thyroid Cancer

This study will investigate the usefulness of an optical probe in the differentiation of thyroid cancer from normal thyroid tissue in a thyroidectomy specimen. This is the next step in the research that this team has conducted through our prior Institutional Review Board (IRB)H-28135, in which the investigators successfully demonstrated that use of the optical probe readings on thyroid specimens ex vivo could successfully discriminate benign from malignant disease. The Elastic Scattering Spectroscopy (ESS) probe has also been IRB approved and a clinical trial conducted in vivo at Boston University/Boston Medical Center by Dr. Satish Singh and Dr. Irving Bigio. The investigators intend to now bring this project to the clinical setting of thyroid disease. The optical real-time readings will be compared to the histological analysis from the same area. Subjects already undergoing thyroid biopsy for thyroid disease including thyroid nodules, thyroid cancer and thyroid goiter with nodules will be eligible to participate. During the already scheduled thyroid procedure using a fine needle aspiration biopsy needle, optical readings will be taken from the thyroid gland and these same areas will then be analyzed in the usual standard fashion. The reading will then be correlated with the histological results. In addition, if lymph nodes are biopsied as part of the evaluation they will also be tested prior to histological standard processing. All specimens and data will be de-identified once data collection and analysis is complete. Our goal is to use optical real-time readings to improve the differential diagnosis of benign from malignant thyroid nodules and avoid surgery for the purpose of diagnosis alone.

Studieoversikt

Status

Fullført

Detaljert beskrivelse

Background: Thyroid cancer is the most common endocrine malignancy. The current gold standard, fine-needle aspiration (FNA) biopsy, yields approximately 10-25% of indeterminate results, leading to patients undergoing thyroidectomy for diagnosis. Elastic scattering spectroscopy (ESS) is a new, minimally invasive optical-biopsy technique, mediated by fiber-optic probes, that which is sensitive to cellular and sub-cellular morphological features. We assessed the potential to incorporate an ESS probe into a 23-gauge needle biopsy to use in preoperative trans-cutaneous biopsy of the thyroid to differentiate benign from malignant thyroid nodules.

Methods: We designed and built a miniaturized ESS probe that can fit through a 23-gauge biopsy needle and tested it under an IRB-approved protocol on 34 patients undergoing ultrasound-guided FNA biopsy of thyroid nodules in the endocrine clinic. ESS data was collected during the conduct of their biopsy using optical 5 repetitive readings from three distinct locations within the thyroid nodule. Using cytology as our gold standard, spectral analyses were compared between benign and malignant thyroid nodules. For indeterminate cytology, final post-surgery pathology of the tissue was used for the comparison.

Studietype

Observasjonsmessig

Registrering (Faktiske)

300

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02118
        • Boston Medical Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Subjects, male and female, undergoing thyroid fine needle aspiration biopsy at Boston Medical Center ages 18 and older. Study population includes all ethnic groups.

Beskrivelse

Inclusion Criteria:

  • Subjects undergoing thyroid biopsy for thyroid nodules, thyroid cancer, and thyroid goiter with nodules. Only those patients requiring sampling under established standard of care criteria and already scheduled to undergo biopsy for clinical purposes will undergo optical biopsy at the same time as their physical biopsy.

Exclusion Criteria:

  • Subjects with nodules smaller than 1 cm, infectious diseases, on medication (such as coumadin) that may interfere with optical readings

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
In Vivo Probe Prediction
Cytology Results

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Assess optical probe for the differentiation of thyroid cancer from normal thyroid tissue and benign thyroid nodules
Tidsramme: 2 years
The objective is to assess a device called an optical probe for the differentiation of thyroid cancer from normal thyroid tissue, benign thyroid nodules or parathyroid glands, and the detection of thyroid cancer within lymph nodes. The gold standard for diagnosis is ultrasound guided fine needle aspiration biopsy of the nodule. Based on cytology from Fine Needle Aspiration (FNA), 10% of nodules are cancer, 70% are benign (not cancer) and 20% are "indeterminate." The proposed device aims to decrease the number of patients that undergo surgery for diagnosis.
2 years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Samarbeidspartnere

Etterforskere

  • Hovedetterforsker: Jennifer Rosen, MD/FACS, Boston University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juni 2011

Primær fullføring (Faktiske)

1. juni 2014

Studiet fullført (Faktiske)

1. juni 2014

Datoer for studieregistrering

Først innsendt

22. juli 2011

Først innsendt som oppfylte QC-kriteriene

22. juli 2011

Først lagt ut (Anslag)

25. juli 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

17. juni 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. juni 2016

Sist bekreftet

1. juni 2016

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • H-29527

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