Breast cancer MedDRA version: 20.0 Level: PT Classification code 10006187 Term: Breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Fluorothymidine (FLT)
Pharmaceutical Form: Solution for injection
INN or Proposed INN: FLT
Other descriptive name: FLUOROTHYMIDINE F-18
Concentration unit: MBq megabecquerel(s)
Concentra
Sponsors
Álvaro Ruibal Morell
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Adult women with breast cancer whose therapeutic plan is neoadjuvant chemotherapy - Negative pregnancy test - Information Sheet and Informed Consent Form signed by the patient Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 175 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Healthy women - Women with breast cancer under 18 - Diabetic women with breast cancer - Pregnant women with breast cancer - Breast feeding women with breast cancer - Women with breast cancer who have undergone a surgical procedure - Women with breast cancer who have received chemotherapy or radiotherapy before the beginning of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main of this study is to evaluate 18F-FLT (Fluorothymidine) as an early indicator of tumor response to neoadjuvant treatment in breast cancer.;Secondary Objective: 1. Study the prognostic power of the new tracers such as 18F-FLT to determine the early response to neoadjuvant treatment 2. Study the correlation between the spatial heterogeneity observed and the response to treatment, as well as the biological characteristics of the tumour 3. Implement software tools which allow information about spatial heterogeneity to be combined with conventional PET parameters based on Standard Uptake Value (SUV) o estimate the probability of treatment response;Primary end point(s): Quantification of SUVmean and SUVmax variables from PET studies performed in each patient;Timepoint(s) of evaluation of this end point: Once all PET/CT images have been acquired, in other words, from the last visit of the last patient | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Quantification of the total volume of the tumoral lesion in the corresponding CT images and correlation between image variables and pathology data;Timepoint(s) of evaluation of this end point: Once all patients have finished the chemotherapy and histological data is available | — |
Countries
Spain
Contacts
Public ContactÁlvaro Ruibal Morell
Álvaro Ruibal Morell
Outcome results
None listed