- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
California
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Costa Mesa, California, Förenta staterna, 92627
- Pacific Breast Care Clinic
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Irvine, California, Förenta staterna, 92612
- Beckman Laser Institute University of California Irvine
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Irvine, California, Förenta staterna, 92612
- University of California, Irvine Medical Center
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San Francisco, California, Förenta staterna, 94110
- University of California San Francisco
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Övrig: DOSI
|
Breast tissue properties scanning
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Concentration of oxy-hemoglobin (HbO2), in blood.
Tidsram: through study completion, an average of 3 years
|
through study completion, an average of 3 years
|
|
Concentration of deoxy-hemoglobin (HHb) in blood.
Tidsram: through study completion, an average of 3 years
|
through study completion, an average of 3 years
|
|
Concentration of total hemoglobin in blood.
Tidsram: through study completion, an average of 3 years
|
through study completion, an average of 3 years
|
|
Water content of tissue (%)
Tidsram: through study completion, an average of 3 years
|
through study completion, an average of 3 years
|
|
Bulk lipid in tissue (%)
Tidsram: through study completion, an average of 3 years
|
through study completion, an average of 3 years
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Bruce J Tromberg, PhD, Beckman Laser Institute
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 20152355
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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