Tests a PET scan imaging agent in people with metastatic breast cancer
Tests a Ga-68-IAC PET scan in adults with spread of breast cancer.
Plain-language title generated from the registry record
Registry title: Safety and Efficacy of Ga68-IAC PET/CT for Diagnosis and Clinical Management in Metastatic Breast Cancer Patients
Key facts
- Where
- Chandigarh and New Delhi, IndiaSee the 2 sites
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT04480619, who can take part
Where in India
- Postgraduate Institute of Medical and ResearchChandigarh, IndiaNo longer taking part
- All India Institute of Medical SciencesNew Delhi, IndiaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Advanced Imaging Projects, LLC
- Trial code
- NCT04480619
- Record updated
- 16 July 2025
- Original description
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.Read full original descriptionShow less
Safety and Efficacy of Ga-68-IAC Positron Emission Tomography (PET/CT) for Diagnosis and Clinical Management in Metastatic Breast Cancer Patients.
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.
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.