This is a phase I/IIa, open label, multicenter interventional study of Gallium-68 radiolabeled Integrin Adhesion Complex antagonist conjugate (Ga-68-IAC) Positron Emission Tomography (PET/CT) imaging, intended for diagnosis, and clinical management of patients with Metastatic breast cancer.
This is a prospective non blinded trial, Phase I/IIa, multicenter, study in a total of up to 25 subjects with angiogenic therapy indication for breast cancer. All patients with confirmed diagnoses will undergo \[18F\]Fluoro-deoxyglucose (18F-FDG) PET/CT (6-12 mCi) and Ga-68-IAC PET/CT 2-5 mCi to evaluate safety, biodistribution, and response to treatment in metastatic breast cancer patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
25
Clinical management and diagnosis of Metastatic Breast Cancer.
Postgraduate Institute of Medical and Research
Chandigarh, India
All India Institute of Medical Sciences
New Delhi, India
University of Witwatersrand
Johannesburg, South Africa
Specific Aims 1:To evaluate the safety, toxicity profile and tolerability of Ga-68-IAC in patients diagnosed with angiogenic breast cancer.
Assess drug safety and tolerability measuring Incidence of adverse events. NCI Common Terminology Criteria for Adverse Events v5.0, where: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening
Time frame: 6 Months
Specific Aims 2:To evaluate biodistribution and dosimetry of Ga-68-IAC
Assess drug safety and tolerability measuring incidence of abnormal vital signs. Vital signs will include measurements of respiratory rate, pulse rate, and systolic and diastolic blood pressure.
Time frame: 6 Months
Specific Aims 3: To determine the recommended phase 2 dose (RP2D) of Ga-68-IAC examination
Assess drug safety and tolerability measuring incidence of abnormal physical examination findings. Physical examination will be summarized for each body system such as head, eyes, ears, nose, and throat, and cardiovascular, dermatological, musculoskeletal, respiratory, gastrointestinal, genitourinary, and neurological systems.
Time frame: 6 Months
Specific Aim 1: To determine the pharmacokinetic and pharmacodynamic profile of Ga-68-IAC
Assess drug uptake using median and maximum standardized uptake values (SUV).
Time frame: 6 Months
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