Status:
NOT_YET_RECRUITING
Safety and Efficacy of Ga68-IAC PET/CT for Diagnosis and Clinical Management in Metastatic Breast Cancer Patients
Lead Sponsor:
Advanced Imaging Projects, LLC
Collaborating Sponsors:
All India Institute of Medical Sciences
Post Graduate Institute of Medical Education and Research, Chandigarh
Conditions:
Angiogenic Breast Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
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,...
Detailed Description
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 wil...
Eligibility Criteria
Inclusion
- 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
- • 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
Key Trial Info
Start Date :
October 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2027
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04480619
Start Date
October 30 2025
End Date
August 30 2027
Last Update
July 16 2025
Active Locations (3)
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1
Postgraduate Institute of Medical and Research
Chandigarh, India
2
All India Institute of Medical Sciences
New Delhi, India
3
University of Witwatersrand
Johannesburg, South Africa