Ultrasound and Near Infrared Imaging for Breast Cancer Diagnosis and Neoadjuvant Chemotherapy Monitoring
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
The investigators propose to validate the utility of the investigators novel hybrid imaging technique for accurate diagnosis of breast lesions, and for assessing chemotherapy response of cancer treatment and predicting treatment efficacy. The investigators unique hybrid technique is implemented by simultaneously deploying near infrared (NIR) optical sensors and a commercial ultrasound (US) transducer mounted on a hand-held probe, and utilizing co-registered lesion structure information provided by ultrasound to improve the inverse optical tomography reconstruction. As a result, the optical tomography assisted with US has overcome problems associated with intense light scattering and has provided reliable tumor angiogenesis distributions. Initial results with a group of 200 biopsied patients have shown that early stage invasive cancers present two-fold greater total hemoglobin concentration on average than fibroadenomas and other benign lesions. Initial results of advanced cancers have shown that the angiogenesis distribution is highly distorted and heterogeneous, and the distorted distributions correlate with histological microvessel density counts and can be used to assess chemotherapy response.
Objective of this study is to validate the investigators initial results that NIR light guided by ultrasound can improve breast cancer diagnosis and monitor chemotherapy response.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Connecticut
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Farmington, Connecticut, Stati Uniti, 06032
- UConn Health
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Women aged 18 years and older who have breast lumps or abnormalities (actual or suspected) are eligible for the study.
- Women and members of all races and ethnic groups are eligible for this study.
- Diagnostic Group: These patients will include women who have breast lumps/lesions visible by ultrasound and are prescribed follow up with an ultrasound-guided biopsy at the UCHC Cancer Center for evaluation and diagnosis of actual/suspected breast abnormalities.
- Neoadjuvant Chemotherapy Group: These patients will include women who have breast lumps/lesions visible by ultrasound and have been diagnosed with breast cancers and will undergo neoadjuvant chemotherapy. These patients may be identified from the diagnostic group or after initial diagnosis. Patients will only be enrolled to one of the two groups.
- Process Validation Group: This group will contain data from about five women who did not have ultrasound visible lumps on the day of the planned biopsy. Data from the NIR/US scan will be used to validate instrument measurements.
Exclusion Criteria:
- All Subjects who fail to meet the inclusion criteria are ineligible for the study.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Diagnostico
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: NIR/US Diagnostic Group
These patients will include women who have breast lumps/lesions visible by ultrasound and are prescribed follow up with an ultrasound-guided biopsy at the UCHC Cancer Center for evaluation and diagnosis of actual/suspected breast abnormalities.
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Patients receiving an ultrasound-guided biopsy will participate in one study visit on the day of the biopsy.
The NIR/US scan will be completed immediately prior to the biopsy procedure and takes about 5-10 minutes to perform.
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Sperimentale: NIR/US Neoadjuvant Chemotherapy Group
These patients will include women who have breast lumps/lesions visible by ultrasound and have been diagnosed with breast cancers and will undergo neoadjuvant chemotherapy.
These patients may be identified from the diagnostic group or after initial diagnosis.
Patients will only be enrolled to one of the two groups.
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Patients may have the NIR/US scan performed at the time of their initial ultrasound-guided biopsy.
In addition, patients in this group may also have NIR/US performed according the schedule in Table 1.
The number of NIR/US study visits for these subjects will vary from 1-11 depending on the subject's treatment regimen.
The expected duration of study participation for these patients is approximately 6 months.
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Altro: NIR/US Process Validation Group
This group will contain data from about five women who did not have ultrasound visible lumps on the day of the planned biopsy.
Data from the NIR/US scan will be used to validate instrument measurements.
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Patients who present with visible lumps at initial ultrasound but do not have ultrasound visible lumps on the day of the biopsy procedure will not require a biopsy.
NIR/US scan will be performed.
Data from the NIR/US scan will be used to validate instrument measurements.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Hemoglobin concentration
Lasso di tempo: 5 years
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The deoxygenated/oxygenated hemoglobin and total hemoglobin concentration are the measured imaging parameters and biopsy results will be used as the 'gold' standard to compare imaging findings.
Hemoglobin concentration is measured in micromolar/liter.
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5 years
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Susan Tannenbaum, MD, UConn Health
Pubblicazioni e link utili
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Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 12-194-6
- R01EB002136 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .