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- Klinische proef NCT02725658
Monitoring and Predicting Breast Cancer Neoadjuvant Chemotherapy Response Using DOSI
Monitoring and Predicting Breast Cancer Neoadjuvant Chemotherapy Response Using Diffuse Optical Spectroscopic Imaging in a Multi-Center Setting
Studie Overzicht
Gedetailleerde beschrijving
There is considerable interest in developing imaging protocols to monitor and predict breast cancer response to neoadjuvant chemotherapy (NAC), which is chemotherapy given before surgical removal of the tumor, both prior to and as early as possible during the course of treatment. The efficacy and practicality of conventional imaging approaches in the NAC setting varies and identifies the need for alternate functional imaging strategies. Diffuse optical spectroscopic imaging (DOSI) is an experimental imaging method that allows patients to be followed before and during treatment with a cost-effective, bedside, handheld scanning probe. DOSI is a non-invasive technology developed at the University of California, Irvine Beckman Laser Institute. Studies will be performed at seven clinical sites on approximately 200 suspected breast cancer patients, of which 150 are expected to undergo neoadjuvant chemotherapy (NAC).
As a primary aim, the investigators will evaluate whether DOSI can predict NAC pathologic complete response (pCR), which is defined as no tumor cell left in the resected tissue at surgery) by the mid-point of the therapy regimen. As non-invasive DOSI is obtained rapidly with no risk/discomfort, this experimental imaging modality could be used as an indicator of pathologic response which has been an established indicator of long-term survival. The investigators long-term goal is to provide oncologists with a relatively simple, risk-free bedside tool that can be used to help inform medical decisions on chemotherapy regimen, duration, and timing of surgery, thereby maximizing therapeutic response and minimizing unnecessary toxicity.
Studietype
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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California
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Costa Mesa, California, Verenigde Staten, 92627
- Pacific Breast Care Clinic
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Irvine, California, Verenigde Staten, 92612
- Beckman Laser Institute University of California Irvine
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Irvine, California, Verenigde Staten, 92612
- University of California, Irvine Medical Center
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San Francisco, California, Verenigde Staten, 94110
- University of California San Francisco
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Females between the ages of 21 and 80. Specific to Study part #1
- Diagnosed with a Breast Imaging-Reporting and Data System score of 4 or higher breast abnormality greater than 1cm in size Specific to Study part #2
- Enrolled in study part #1
- Diagnosed with histologically-proven invasive breast cancer
- Prescribed neoadjuvant chemotherapy for breast cancer
Exclusion Criteria:
- Pregnant
- Unable to give written, informed consent.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Ander: DOSI
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Breast tissue properties scanning
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Concentration of oxy-hemoglobin (HbO2), in blood.
Tijdsspanne: through study completion, an average of 3 years
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through study completion, an average of 3 years
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Concentration of deoxy-hemoglobin (HHb) in blood.
Tijdsspanne: through study completion, an average of 3 years
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through study completion, an average of 3 years
|
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Concentration of total hemoglobin in blood.
Tijdsspanne: through study completion, an average of 3 years
|
through study completion, an average of 3 years
|
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Water content of tissue (%)
Tijdsspanne: through study completion, an average of 3 years
|
through study completion, an average of 3 years
|
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Bulk lipid in tissue (%)
Tijdsspanne: through study completion, an average of 3 years
|
through study completion, an average of 3 years
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Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Bruce J Tromberg, PhD, Beckman Laser Institute
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 20152355
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
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