- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00978770
MRI in Predicting Early Response to Chemotherapy in Patients With Locally Advanced Breast Cancer
Neo Comice Pilot; Efficacy of Advanced Semi-automated Functional Magnetic Resonance (MR) Imaging in the Early Prediction of Response of Locally Advanced Breast Cancer to Neoadjuvant Chemotherapy
RATIONALE: Diagnostic procedures such as MRI scans may help predict early response to treatment in patients with breast cancer undergoing chemotherapy.
PURPOSE: This phase II trial is studying MRI in predicting early response to chemotherapy in patients with locally advanced breast cancer.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
OBJECTIVES:
- To determine the technical feasibility of using MRI in a multicenter setting using the most commonly available magnetic resonance (MR) systems (i.e., is the trial able to scan patients to a specific protocol, using different types of MRI machine) measured by the number of MRI scans not completed to technical specifications (i.e., incorrect sequences or incomplete scans) or trial protocol (i.e., scans not completed or completed at the wrong time).
- To determine how reliably the imaging data can be analyzed in a centralized, semi-automated manner (i.e., can MRI data be reliably transferred from different centers and analyzed using software based in the center for MR investigations at the University of Hull) measured by the number of cases where automated data analysis of completed MRI scans was not possible (i.e., data could not be analyzed at all or data required manual analysis).
OUTLINE: This is a multicenter study.
Patients undergo magnetic resonance imaging (MRI) scans at baseline, 4-7 days after beginning after the first course of chemotherapy, at the end of their second course of chemotherapy, and at the end of their fourth course of chemotherapy (first regimen). MRI techniques may include dynamic contrast-enhanced, diffusion-weighted, and spectroscopic.
Studietyp
Inskrivning (Förväntat)
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
England
-
Hull, England, Storbritannien, HU3 2KZ
- Cactus Clinical Trials Unit
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
DISEASE CHARACTERISTICS:
Newly diagnosed, histologically proven breast cancer
- Stage T2-4B, N0-3C, and M0 disease
- Locally advanced primary disease
- Underwent both x-ray mammography and breast ultrasound scanning during the current treatment episode
- Scheduled for neoadjuvant chemotherapy
PATIENT CHARACTERISTICS:
- Not pregnant or nursing
- Medically stable
- No renal failure
- No serious breast trauma within the past 3 months
- No known allergic reaction associated with previous administration of a paramagnetic contrast agent
No known contraindication to magnetic resonance (MR) scanning
- Must pass the normal safety requirements of MR, particularly pacemakers and cardiac defibrillators
- No disability preventing MR scanning in the prone position
- No body habitus incompatible with MR system entry
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior chemotherapy
No prior surgery or radiotherapy for cancer in the ipsilateral breast
- More than 4 months since prior surgery to the ipsilateral breast for benign breast disease
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
Vad mäter studien?
Primära resultatmått
Resultatmått |
---|
Failed scan rate (i.e., the number of scans that failed protocol) grouped by cause, including patient refusal, protocol violation in timing, major errors in scan protocols, and minor errors in scan protocol
|
Failed automated MRI-scan data-analysis rate (i.e., number of scans that required manual reading and number of protocol-compliant scans that were unreadable, subdivided according to whether the scans were technically compliant or not)
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Lindsay W. Turnbull, MD, Hull Royal Infirmary
Studieavstämningsdatum
Studera stora datum
Studiestart
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CCTU-Neo-COMICE
- CDR0000649054 (Registeridentifierare: PDQ (Physician Data Query))
- ISRCTN42613663
- EU-20968
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