- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02599974
PET-CT in the Initial Staging of Breast Cancer and in the Early Assessment of Response to Neoadjuvant Chemotherapy (ASAINT)
Role of Fluorodeoxyglucose (FDG) PET-CT in the Initial Staging of Breast Cancer (ASAINT 1) and in the Early Assessment of Response to Neoadjuvant Chemotherapy (ASAINT 2)
The two main objectives of this prospective study are:
- to identify those patients for whom pre-treatment FDG (Fluorodeoxyglucose) PET (positron emission tomography) CT-scan (Computed tomography scan) provides useful information for the treatment of breast cancer (ASAINT 1),
- to improve FDG PET-CT-scan imaging criteria for assessing response to neoadjuvant therapy early, in M0-patients (ASAINT 2).
The secondary objective is to better understand the interactions between the imaging parameters of FDG PET-CT-scan and biological and histological features of breast cancer .
This is a non-interventional study. Two PET-CT-scans are performed, one before starting treatment, and the other after 2 cycles of neoadjuvant chemotherapy. The two PET-CT-scans are prescribed by oncologists from the center of breast diseases Unit at St. Louis hospital, in Paris, France. Oncologists provide clear information to the patients on the purpose of the examination. The examinations are performed in the nuclear medicine department at St. Louis hospital. PET-CT-scans data, tumor characteristics, results of other imaging and biological tests, results of surgery and patient's follow-up are summarized in a "de-identified" file. This file has been declared to the National Commission on Informatics and Liberties (CNIL). The data in this file are established prospectively and secondary analyzed to assess the precise role of PET-CT-scans in the initial staging of breast cancer and to determine the optimal PET-CT-scans criteria to evaluate response to neoadjuvant treatment early.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
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Paris, Frankrig, 75010
- Rekruttering
- Hopital Siant-louis
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Kontakt:
- David Groheux, MD-PHD
- Telefonnummer: +33 630603009
- E-mail: david.groheux@aphp.fr
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria :
- Histologically confirmed breast cancer
- Stage II and III breast cancer
- Neo-adjuvant chemotherapy
- Baseline PET-CT-scan (ASAINT 1 and 2)
- PET-CT-scans after second cycle of neo-adjuvant chemotherapy (ASAINT 2)
- Tumor biopsy for diagnosis and biological analysis with hormone receptors and Human Epidermal Growth Factor Receptor-2 (HER2) available
- Surgical intervention after completion of neo-adjuvant chemotherapy
- Evaluable pathological response
Exclusion Criteria :
- Other tumor localization
- Non controlled diabetes mellitus
- Pregnancy
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Pathological complete response in M0 patients at baseline PET (stage II-III)
Tidsramme: 18 weeks
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Absence of residual cancer cells in the primary breast tumor and in axillary lymph nodes
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18 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of distant metastases (M1 patients at baseline PET)
Tidsramme: 2 weeks
|
Detection of distant metastases by FDG PET-CT
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2 weeks
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Number of metastatic nodes at baseline PET (axillary and extra-axillary)
Tidsramme: 2 weeks
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Detection of metastatic axillary and extra-axillary nodes by FDG PET-CT
|
2 weeks
|
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Standard uptake value on the FDG-PET (Fluorodeoxyglucose positron emission tomography)
Tidsramme: 2 weeks
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2 weeks
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Patients overall survival
Tidsramme: 5 years
|
5 years
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|
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event free survival
Tidsramme: 5 years
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5 years
|
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Patients overall survival
Tidsramme: 3 years
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3 years
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begivenhedsfri overlevelse
Tidsramme: 3 år
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3 år
|
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Patients overall survival
Tidsramme: 2 years
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2 years
|
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event free survival
Tidsramme: 2 years
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2 years
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Total lesion glycolysis on the FDG-PET (Fluorodeoxyglucose positron emission tomography)
Tidsramme: 2 weeks
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2 weeks
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Metabolic tumor volume on the FDG-PET (Fluorodeoxyglucose positron emission tomography)
Tidsramme: 2 weeks
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2 weeks
|
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Tumor heterogeneity determined on the FDG-PET (Fluorodeoxyglucose positron emission tomography)
Tidsramme: 2 weeks
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2 weeks
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: David Groheux, MD-PhD, APHP, IUH, University Paris Diderot, Paris 7, SPC
- Studiestol: Matthieu Resche-Rigon, MD-PHD, DRCD APHP Paris
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NI 12020 ASAINT
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