Safety and Efficacy of Ga68 Αvβ3 IAC PET/CT for Diagnosis and Clinical Management in Angiogenic Breast Cancer Patients

Study Overview
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Brief Summary
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This is a phase I/IIa, open label, multicenter interventional study of Gallium-68 radiolabeled PEG-αvβ3-Integrin Adhesion Complex antagonist conjugate (Ga-68-PEG-Αvβ3-IAC) Positron Emission Tomography (PET/CT) imaging, intended for diagnosis, and clinical management of patients with angiogenic breast cancer.

Detailed Description
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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-PEG-αvβ3 IAC PET/CT 2-5 mCi to evaluate safety, biodistribution, and response to treatment in angiogenic breast cancer patients.

Official Title
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Safety and Efficacy of Ga-68-Αvβ3 IAC Positron Emission Tomography (PET/CT) for Diagnosis and Clinical Management in Angiogenic Breast Cancer Patients.

Conditions
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Diagnosis and Clinical Management of Angiogenic Breast Cancer

Intervention / Treatment
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* Diagnostic Test: Ga-68-PEG-Αvβ3-IAC PET/CT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with solid tumors (either 3+ by immunohistochemistry or with evidence of gene amplification (>2.0) by fluorescence in situ hybridization (FISH)) At least 18 years of age Able to provide informed consent. Karnofsky score greater than 50 Females of childbearing potential must have a negative pregnancy test at screening/baseline AIP-301 Ga-68 positive scan define by SUV greater than 10. Adequate organ function, defined as: Absolute neutrophil count (ANC) ≥ 1.5 x 109/L. Hemoglobin (Hb) ≥9 g/dl (transfusion or use of EPO is permitted). Platelets > 100,000/mm3 Creatinine ≤ 1.5 x normal value based on the Cock Gault (CG) equation. AST or ALT ≤ 2.5 x ULN (or ≤5 x ULN in case of liver metastasis) Alkaline phosphatase ≤2.5 x ULN. Alkaline phosphatase may be more than 2.5 x ULN only in the case of bone metastases, and AST and ALT less than 1.5 x ULN. Total bilirubin ≤1.5 mg/dl (higher bilirubin levels are permitted if the patient has Gilbert's syndrome). Baseline LVEF ≥50% measured using echocardiogram or equilibrium isotopic ventriculography (MUGA). Exclusion Criteria: • Serum creatinine >3.0 mg/dL (270 μM/L) Hepatic enzyme levels more than 5 times upper limit of normal. Known severe allergy or hypersensitivity to IV radiographic contrast. Use of any other investigational product or device within 30 days prior to dosing or known requirement for any other investigational agent prior to completion of all scheduled study assessments. Patients with a body weight of 400 pounds or more or not able to enter the bore of the PET/CT scanner due to BMI, because of the compromise in image quality with CT, PET/CT and MRI that will result. Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.). Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.) Recognized concurrent active infection (e.g., HIV) Previous Grade 3 or higher allergic reaction to Trastuzumab that resulted in discontinuation of Trastuzumab therapy. Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance. Adult patients who require monitored anesthesia for PET scanning

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Ga-68 PEG-Αvβ3-IAC PET/CT
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ga-68-PEG-Αvβ3-IAC PET/CT<br>Companion Ga-68 PET diagnostic for tumor targeted therapy | Diagnostic Test: Ga-68-PEG-Αvβ3-IAC PET/CT<br>* PET Diagnostic Agent<br>* Other names: Ga-68Αvβ3-IAC PET/CT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specific Aims 1:To evaluate the safety, toxicity profile and tolerability of Ga-68-PEG-αvβ3-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 | 6 Months | 
| Specific Aims 2:To evaluate biodistribution and dosimetry of Ga-68-PEG-αvβ3-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. | 6 Months | 
| Specific Aims 3: To determine the recommended phase 2 dose (RP2D) of Ga-68-PEG-αvβ3-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. | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specific Aim 1: To determine the pharmacokinetic and pharmacodynamic profile of Ga-68-PEG-αvβ3-IAC | Assess drug uptake using median and maximum standardized uptake values (SUV). | 6 Months |