- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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.
Studienübersicht
Status
Bedingungen
Studientyp
Einschreibung (Voraussichtlich)
Kontakte und Standorte
Studienorte
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Paris, Frankreich, 75010
- Rekrutierung
- 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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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Pathological complete response in M0 patients at baseline PET (stage II-III)
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Number of distant metastases (M1 patients at baseline PET)
Zeitfenster: 2 weeks
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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)
Zeitfenster: 2 weeks
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Detection of metastatic axillary and extra-axillary nodes by FDG PET-CT
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2 weeks
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Standard uptake value on the FDG-PET (Fluorodeoxyglucose positron emission tomography)
Zeitfenster: 2 weeks
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2 weeks
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Patients overall survival
Zeitfenster: 5 years
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5 years
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event free survival
Zeitfenster: 5 years
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5 years
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Patients overall survival
Zeitfenster: 3 years
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3 years
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Ereignisfreies Überleben
Zeitfenster: 3 Jahre
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3 Jahre
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Patients overall survival
Zeitfenster: 2 years
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2 years
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event free survival
Zeitfenster: 2 years
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2 years
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Total lesion glycolysis on the FDG-PET (Fluorodeoxyglucose positron emission tomography)
Zeitfenster: 2 weeks
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2 weeks
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Metabolic tumor volume on the FDG-PET (Fluorodeoxyglucose positron emission tomography)
Zeitfenster: 2 weeks
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2 weeks
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Tumor heterogeneity determined on the FDG-PET (Fluorodeoxyglucose positron emission tomography)
Zeitfenster: 2 weeks
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2 weeks
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Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: David Groheux, MD-PhD, APHP, IUH, University Paris Diderot, Paris 7, SPC
- Studienstuhl: Matthieu Resche-Rigon, MD-PHD, DRCD APHP Paris
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- NI 12020 ASAINT
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