Safety and Efficacy of Ga68-IAC PET/CT for Diagnosis and Clinical Management in Metastatic Breast Cancer Patients
NCT ID: NCT04480619
Last Updated: 2025-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1/PHASE2
25 participants
INTERVENTIONAL
2025-10-30
2027-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Ga-68-IAC PET/CT
Companion Ga-68 PET diagnostic for tumor targeted therapy
Ga-68-IAC
Clinical management and diagnosis of Metastatic Breast Cancer.
Interventions
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Ga-68-IAC
Clinical management and diagnosis of Metastatic Breast Cancer.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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All India Institute of Medical Sciences
OTHER
Post Graduate Institute of Medical Education and Research, Chandigarh
OTHER
University of Witwatersrand, South Africa
OTHER
US Department of Veterans Affairs
FED
Advanced Imaging Projects, LLC
INDUSTRY
Responsible Party
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Locations
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Postgraduate Institute of Medical and Research
Chandigarh, , India
All India Institute of Medical Sciences
New Delhi, , India
University of Witwatersrand
Johannesburg, , South Africa
Countries
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Central Contacts
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Facility Contacts
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References
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Baum RP, Kulkarni HR, Muller D, Satz S, Danthi N, Kim YS, Brechbiel MW. First-In-Human Study Demonstrating Tumor-Angiogenesis by PET/CT Imaging with (68)Ga-NODAGA-THERANOST, a High-Affinity Peptidomimetic for alphavbeta3 Integrin Receptor Targeting. Cancer Biother Radiopharm. 2015 May;30(4):152-9. doi: 10.1089/cbr.2014.1747.
Kim YS, Nwe K, Milenic DE, Brechbiel MW, Satz S, Baidoo KE. Synthesis and characterization of alphavbeta(3)-targeting peptidomimetic chelate conjugates for PET and SPECT imaging. Bioorg Med Chem Lett. 2012 Sep 1;22(17):5517-22. doi: 10.1016/j.bmcl.2012.07.024. Epub 2012 Jul 14.
Other Identifiers
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145314
Identifier Type: -
Identifier Source: org_study_id
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