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

May 27, 2022 updated by: Advanced Imaging Projects, LLC

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • India
      • Chandigarh, India
        • Postgraduate Institute of Medical and Research
        • Contact:
      • New Delhi, India
        • All India Institute of Medical Sciences
        • Contact:
  • South Africa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

    1. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L.
    2. Hemoglobin (Hb) ≥9 g/dl (transfusion or use of EPO is permitted).
    3. Platelets > 100,000/mm3
    4. Creatinine ≤ 1.5 x normal value based on the Cock Gault (CG) equation.
    5. AST or ALT ≤ 2.5 x ULN (or ≤5 x ULN in case of liver metastasis)
    6. 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.
    7. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ga-68-PEG-Αvβ3-IAC PET/CT
Companion Ga-68 PET diagnostic for tumor targeted therapy
Diagnostic test: Ga-68-PEG-Αvβ3-IAC PET/CT
PET Diagnostic Agent
Other Names:
  • Ga-68Αvβ3-IAC PET/CT

What is the study measuring?

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.
Time Frame: 6 Months
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
Time Frame: 6 Months
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
Time Frame: 6 Months
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
Time Frame: 6 Months
Assess drug uptake using median and maximum standardized uptake values (SUV).
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Advanced Imaging Projects, LLC

Collaborators

All India Institute of Medical Sciences, New Delhi
US Department of Veterans Affairs
University of Witwatersrand, South Africa
Post Graduate Institute of Medical Education and Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 30, 2022

Primary Completion (Anticipated)

August 30, 2022

Study Completion (Anticipated)

August 30, 2024

Study Registration Dates

First Submitted

June 30, 2020

First Submitted That Met QC Criteria

July 20, 2020

First Posted (Actual)

July 21, 2020

Study Record Updates

Last Update Posted (Actual)

June 2, 2022

Last Update Submitted That Met QC Criteria

May 27, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 145314

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Data will be available after completion of clinical trial

IPD Sharing Time Frame

2 years

IPD Sharing Supporting Information Type

  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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