Diffuse Optical Tomography (DOT) for Monitoring Response to Neoadjuvant (Preoperative) Chemotherapy in Breast Cancer (DOT)
2. maj 2013 opdateret af: Yap Yoon Sim, National Cancer Centre, Singapore
The aim of the study is to determine if DOT can detect response early in breast cancer patients undergoing neoadjuvant chemotherapy.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
The pilot study will enrol up to ten patients over one year.
Patients receiving neoadjuvant chemotherapy for breast cancer will undergo baseline clinical examination, mammography, ultrasound, MRI and DOT before commencement of treatment.
DOT will be repeated at 1,3,6 weeks after chemotherapy, and at the end of each chemotherapy regimen.
Ultrasound will be repeated every 6 weeks and at the end of treatment.
Mammography and MRI will be repeated once at the end of treatment before surgery.
A breast pathologist will evaluate the subtype of breast cancer and the pathologic response of the operative specimen at the end of treatment.
Patient satisfaction questionnaires will be administered to evaluate their preferences for DOT, ultrasound, mammography and MRI scanning at the beginning and the end of the study.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
8
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Singapore, Singapore, 169610
- National Cancer Centre Singapore
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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
21 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Approximately 60 patients are prescribed neaodjuvant chemotherapy for breast cancer at National Cancer Centre Singapore annually.
Accrual is expected to be 10 patients per year.
Up to 10 patients will be recruited for this study.
Beskrivelse
Inclusion Criteria:
- Patients receiving neoadjuvant chemotherapy for breast cancer.
- Patients with locally advanced breast tumours or large operable tumours who require neoadjuvant treatment for downstaging.
- Histological confirmation of invasive breast carcinoma.
- Patients with metastatic disease may be eligible if they have oligometastatic disease and breast surgery after neoadjuvant chemotherapy is planned.
- Signed informed consent
- Age equal to or more than 21 years
- Life expectancy greater than 12 weeks.
- ECOG performance status 0-2
Exclusion Criteria:
- Fungating or ulcerated tumours
- Inability to provide informed consent
- Anticipated inability to follow-up patient for response to chemotherapy
- Any contraindication to undergoing ultrasound, MRI, MMG or DOT
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Parameters derived from the optical images acquired with the DOT system
Tidsramme: These parameters will be obtained from patients during neoadjuvant chemotherapy process, which is up to an average of 6 months
|
The primary parameters derived from the optical images acquired with the DOT system include: The volume of tumor microvasculature V, the total haemoglobin concentration (THC), and the blood volume index BVI (=VC). Other available optical parameters are: blood oxygenation in the tumor microvasculature (SO2), its spatial distribution and dynamic fluctuation; dynamic blood perfusion. These parameters will be compared with histopathological response. |
These parameters will be obtained from patients during neoadjuvant chemotherapy process, which is up to an average of 6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in DOT parameters such as BVI, SO2, blood perfusion dynamic fluctuation
Tidsramme: These parameters will be obtained from patients during neoadjuvant chemotherapy process, which is up to an average of 6 months
|
The change in DOT parameters such as BVI, SO2, blood perfusion dynamic fluctuation will be correlated with response based on clinical examination, ultrasound, MMG and MRI. Standard definitions for clinical response will be used to classify patients into four categories: complete response (CR), partial response (PR), progressive disease (PD) and stable disease (SD). |
These parameters will be obtained from patients during neoadjuvant chemotherapy process, which is up to an average of 6 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Yoon Sim Yap, MBBS, FRACP, National Cancer Centre, Singapore
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
1. august 2011
Primær færdiggørelse (Faktiske)
1. maj 2013
Studieafslutning (Faktiske)
1. maj 2013
Datoer for studieregistrering
Først indsendt
12. juli 2011
Først indsendt, der opfyldte QC-kriterier
13. juli 2011
Først opslået (Skøn)
14. juli 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
3. maj 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. maj 2013
Sidst verificeret
1. maj 2013
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 11-7-BRE
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 .