Angiogenic Breast CancerPhase 1/2ShivaNCT04480619
Safety and Efficacy of Ga68-IAC PET/CT for Diagnosis and Clinical Management in Metastatic Breast Cancer Patients
A Phase 1/2 study testing Ga-68-IAC in people with Angiogenic Breast Cancer, run by Advanced Imaging Projects, LLC at 3 sites in 2 countries.
Trial 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, intended for diagnosis, and clinical management of patients with Metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Angiogenic Breast Cancer
- What is being tested?
- Ga-68-IAC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 30 Oct 2025to 30 Aug 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 16Show fewer
- 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).
Who cannot join
- • 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.).
Show all 10Show fewer
- 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
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
India2 sites
Postgraduate Institute of Medical and Research
Chandigarh
B.R. Mittal, M.D./Ph.D., brmittal@yahoo.com
All India Institute of Medical Sciences
New Delhi
C.S. Ball, 01126546477, drcsbal@gmail.com
South Africa1 site
University of Witwatersrand
Johannesburg
Mboyo Vangu, M.D./Ph.D., 0832670004, Mboyo-Di-Tamba.Vangu@wits.ac.za
About this study
Official title: 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.
Read the 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-IAC PET/CT 2-5 mCi to evaluate safety, biodistribution, and response to treatment in metastatic breast cancer patients.
- Conditions
- Angiogenic Breast Cancer
- Being tested
- Ga-68-IAC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ga-68-IACDiagnostic test
Also called Ga-68-IAC PET/CT
Clinical management and diagnosis of Metastatic Breast Cancer.
| Study group | Role | What they receive |
|---|---|---|
| Ga-68-IAC PET/CT | Experimental | Companion Ga-68 PET diagnostic for tumor targeted therapy Receives: Diagnostic Test: Ga-68-IAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specific Aims 1:To evaluate the safety, toxicity profile and tolerability of Ga-68-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
Measured: 6 Months
Specific Aims 2:To evaluate biodistribution and dosimetry of Ga-68-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.
Measured: 6 Months
Specific Aims 3: To determine the recommended phase 2 dose (RP2D) of Ga-68-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.
Measured: 6 Months
Secondary outcomes (1)
Specific Aim 1: To determine the pharmacokinetic and pharmacodynamic profile of Ga-68-IAC
Assess drug uptake using median and maximum standardized uptake values (SUV).
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start30 Oct 2025 (estimated)
- Primary completion30 May 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Angiogenic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Ga-68-AC PET/CT
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Advanced Imaging Projects, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- All India Institute of Medical Sciences, Post Graduate Institute of Medical Education and Research, Chandigarh, University of Witwatersrand, South Africa, US Department of Veterans Affairs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04480619
- Sponsor's protocol ID
- 145314
- Acronym
- Shiva
- Status last verified
- Jul 2025
- First submitted
- 30 Jun 2020
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available after completion of clinical trial
Publications
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.
PubMed 25945808Kim 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.
PubMed 22853992
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Ga-68-IAC Positron Emission Tomography (PET/CT) for Diagnosis and Clinical Management in Metastatic Breast Cancer Patients.
- ClinicalTrials.gov ID
- NCT04480619
- Acronym / sponsor ID
- Shiva / 145314
- Conditions
- Angiogenic Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Advanced Imaging Projects, LLCIndustry (pharma, biotech, devices)
- Collaborators
- All India Institute of Medical Sciences, Post Graduate Institute of Medical Education and Research, Chandigarh, University of Witwatersrand, South Africa, US Department of Veterans Affairs
- Study start
- 30 Oct 2025 (estimated)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 21 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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-IAC PET/CT 2-5 mCi to evaluate safety, biodistribution, and response to treatment in metastatic breast cancer patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Ga-68-AC PET/CT
| Arm | Type | Receives |
|---|---|---|
| Ga-68-IAC PET/CT | Experimental | Diagnostic Test: Ga-68-IACCompanion Ga-68 PET diagnostic for tumor targeted therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients with solid tumors (either 3+ by immunohistochemistry or with evidence of gene amplification (>2.0) by fluorescence in situ hybridization (FISH))
- 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:
Key exclusion criteria (10 listed)
- • Serum creatinine >3.0 mg/dL (270 μM/L)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ga-68-IACAlso: Ga-68-IAC PET/CTClinical management and diagnosis of Metastatic Breast Cancer. | Diagnostic test | Ga-68-IAC PET/CT |
Primary outcome
Specific Aims 1:To evaluate the safety, toxicity profile and tolerability of Ga-68-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
Specific Aims 2:To evaluate biodistribution and dosimetry of Ga-68-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.
Specific Aims 3: To determine the recommended phase 2 dose (RP2D) of Ga-68-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.
1 secondary outcome
Specific Aim 1: To determine the pharmacokinetic and pharmacodynamic profile of Ga-68-IAC
Time frame: 6 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Results publication: PubMed 25945808Baum 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.
- Results publication: PubMed 22853992Kim 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.
- Individual participant dataSharing planned: Yes. Data will be available after completion of clinical trial
Related trials for Angiogenic Breast Cancer
Not yet recruitingPhase 2
Neoadjuvant Angiogenesis-Targeting Bispecific Chemoimmunotherapy for TNBC
Breast Cancer, Triple Negative Breast Cancer
RecruitingPhase 2
Pembrolizumab + Paclitaxel +/- Bevacizumab for Triple-negative Breast Cancer
Recurrent Triple-Negative Breast Cancer
Not yet recruiting
Targeting Stress-Driven Inflammatory and Angiogenic Pathways With Brief ACT to Enhance Neoadjuvant Chemotherapy Response in Locally Advanced Breast Cancer
Breast Cancer, Breast Neoplasm Female
Not yet recruitingPhase 2
Huaier Granule and Proteinuria
Proteinuria, Breast Cancer Patients
RecruitingPhase 3
Randomized, Open, Controlled, Multicenter Phase III Clinical Study of Fluzoparib in Combination With Apatinib Versus Investigator-Selected Chemotherapy for HRD-Positive/HER2-negative Advanced Breast Cancer
Fludzoparib" and Anti-angiogenic, HRD-positive/HER2-negative Advanced Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ga-68-IAC in people with Angiogenic Breast Cancer, run by Advanced Imaging Projects, LLC at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in India, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stanley Satz, Ph.D. (561-561 286-6842, ssatz@advancedimagingprojects.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specific Aims 1:To evaluate the safety, toxicity profile and tolerability of Ga-68-IAC in patients diagnosed with angiogenic breast cancer. (time frame: 6 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04480619, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.