Prospective cohort diagnostic test accuracy study in 30 breast cancer patients scheduled for neoadjuvant chemotherapy (15 of which with Pgp-positive and 15 with Pgp-negative tumors) and 10 low grade glioma patients (group G) scheduled for surgical tumor removal. MedDRA version: 18.1 Level: LLT Classification code 10006153 Term: Brain tumor System Organ Class: 100000004864 MedDRA version: 18.1 Level: LLT Classification code 10006192 Term: Breast cancer NOS System Organ Class: 100000004864
Conditions
Interventions
Trade Name: N/A
Product Name: 11C-tariquidar
Product Code: 11C-tari
Pharmaceutical Form:
INN or Proposed INN: 11C-tariquidar
Concentration unit: MBq megabecquerel(s)
Concentration type: range
Concent
Sponsors
Medizinische Universität Wien
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Sex: female (only group B), male and female (group G) • Age: >18years old • Breast cancer patients scheduled for neoadjuvant chemotherapy (group B) or low grade glioma patients (group G) scheduled for surgical tumor removal. • Histologically confirmed breast cancer with estimated lesion size of >2 cm (gor group B only) • Availability of tumor biopsy at the time of diagnosis for IHC and/or WB analysis • Volunteers must sign the informed consent prior to inclusion in the study • Ability to comprehend the full nature and purpose of the study, including possible risks and side effects 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 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Any abnormality found as part of the pretreatment screening or in any of the laboratory tests performed that the investigators considers might influence the outcome of the study (e.g. co-morbidities) • Participation in a clinical study with a radioactive substance in the last 12 months • Intake of any medication during two weeks before the start of the study, which the investigator considers may affect the validity of the study, due to interference with CYP3A4 and/or Pgp • For female subjects in child-bearing age: Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: ? To correlate PET imaging outcome parameters (e.g. volume of distribution (VT) of [11C]tariquidar in tumor tissue) at staging with Pgp expression levels measured by IHC and/or at baseline (diagnostic biopsy);Secondary Objective: ? To correlate [11C]tariquidar PET imaging outcome parameters and Pgp expression levels at baseline with response to neoadjuvant chemotherapy measured by Response Evaluation Criteria In Solid Tumors (RECIST) ? Assess safety and tolerability of [11C]tariquidar PET imaging ? To correlate changes in [11C]tariquidar PET imaging outcome parameters with changes in Pgp expression levels before and after chemotherapy (optional) ? To correlate [11C]tariquidar PET imaging outcome parameters and Pgp expression levels measured after chemotherapy with response to neoadjuvant chemotherapy measured by RECIST criteria (optional) ;Primary end point(s): ? Correlation of [11C]tariquidar PET imaging outcome parameters at staging with Pgp expression levels measured by IHC at baseline (diagnostic biopsy) ;Timepoint(s) of evaluation of this end point: after first PET scan | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? Correlation of [11C]tariquidar PET imaging outcome parameters and Pgp expression levels at baseline with response to neoadjuvant chemotherapy measured by RECIST criteria;Timepoint(s) of evaluation of this end point: ? after end of neoadjuvant chemotherapy (expected duration: 3 weeks) | — |
Countries
Austria
Contacts
Public ContactDepartment of Clinical Pharmacology
Medizinische Universität wien
Outcome results
None listed