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Clinical Trial · NCT00771381
A Study to Determine the Value of 18F-FAZA PET Imaging in Patients With Breast Cancer
Overview
In about half the cases of breast cancer, there is hypoxic (no, or little oxygen) tissue present. Hypoxic cells can be resistant to treatment and may cause increased tumour growth. This study will use 18F-FAZA PET scans before surgery or treatment to assess whether patients have hypoxic tumours. The results will be compared to tissue samples removed during surgery and to the distribution of 18F-FDG.
Sponsor
AHS Cancer Control Alberta
Phase
Phase 2
Contacts
Emmanuel W Hudson, MD (PRINCIPAL_INVESTIGATOR)
ClinicalTrials.gov
NCT00771381Drug / Compound
FAZA
Isotope(s):
FLUORINE-18
Radioisotope: F-18
Theranostic Role: PET Imaging
T1/2 (Half-Life): 1.8 Hours
Decay Mode: POSITRON β+ (96.7%), ELECTRON CAPTURE (3.3%), GAMMA 511 keV
Energy: Eβ+ 635 keV
Range: N/A
Decay Daughters: O18 (Stable)
Status: FDA Approvals: FDG (Cancer 2005): GLUDEF®, METATRACE® AXUMIN® (2016), PYLARIFY® (2023), POSLUMA® (2024)
Target(s):
- Hypoxia
Ligand Class: Small Molecules
FDB
Isotope(s):
FLUORINE-18
Radioisotope: F-18
Theranostic Role: PET Imaging
T1/2 (Half-Life): 1.8 Hours
Decay Mode: POSITRON β+ (96.7%), ELECTRON CAPTURE (3.3%), GAMMA 511 keV
Energy: Eβ+ 635 keV
Range: N/A
Decay Daughters: O18 (Stable)
Status: FDA Approvals: FDG (Cancer 2005): GLUDEF®, METATRACE® AXUMIN® (2016), PYLARIFY® (2023), POSLUMA® (2024)
Target(s):
- Glucose Transport
Ligand Class: Small Molecules
Eligibility
Inclusion
- ECOG performance score ≤ 2
- Pathologically proven invasive duct carcinoma of the breast (FNA or core biopsy), T1-T4(T ≥ 1.5 cm)
- FluGlucoScan Injection and 18F-FAZA PET scans performed prior to treatment.
- Able and willing to follow instructions and comply with the protocol
- FluGlucoScan Injection and 18F-FAZA PET scans performed within 4 weeks prior to their definitive surgery if subject does not have neoadjuvant therapy.
Exclusion
- Excisional biopsy of the primary breast tumour has been performed
- Women with an invasive carcinoma of the breast that is not predominantly of the invasive duct subtype
- Women who are nursing or pregnant.
- Primary breast carcinoma previously treated.
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