PET imaging trial partnerships
Cardiac PET trials, run end to end in Miami
Amavita Research is a clinical trial site and PET imaging trial partner. Our North Miami Beach site enrolls cardiovascular trials directly, and we run cardiac PET and radiopharmaceutical studies end to end — from first-in-human healthy-volunteer PET studies through later-phase trials — with cardiac PET imaging delivered through our qualified imaging network.
Cardiovascular drug and tracer development increasingly depends on cardiac PET. Myocardial perfusion PET quantifies flow. Viability imaging guides revascularization decisions. Coronary flow reserve is becoming a trial endpoint in its own right. And the pipeline of novel cardiac tracers — 18F-labeled perfusion agents, amyloid and inflammation tracers — needs sites that can handle radiopharmaceuticals, not just read scans.
Amavita Research is built for that pipeline. Our North Miami Beach site enrolls cardiovascular trials directly — 7 active studies across heart failure, hypertension, acute coronary syndrome, structural heart, and peripheral artery disease — and runs cardiac PET and radiopharmaceutical studies end to end: protocol execution, patient enrollment, PK blood sampling, dosimetry support, and safety follow-up under one PI team. Cardiac PET imaging executes through our qualified imaging network with GCP and 21 CFR Part 11 controls.
The operating discipline is the same one behind our 41-day CTA-to-first-patient-in record: GCSA-certified processes, a single BD owner in Nereisy Alonso, COO, and a diverse Miami enrollment population that supports FDA Diversity Action Plan targets.
Cardiac PET endpoints we run
- Myocardial perfusion PET — rest/stress flow quantification
- On-site N-13 ammonia production for cardiac PET — unique in Miami
- Cardiac amyloidosis imaging
- Vascular inflammation tracers
- Novel cardiac tracers, including 18F-labeled agents
End-to-end trial execution
- First-in-human healthy-volunteer PET studies through Phase 2-3 therapeutic trials
- Patient enrollment, investigational treatment, and safety follow-up at our Miami site
- PK blood sampling, dosimetry support, and standard safety assessments
- Radiation safety and radiopharmaceutical handling through a licensed PET facility
What sponsors get
- One contract, one project manager, one PI team
- Feasibility in days, with a 20-minute sponsor consultation led by our COO
- GCP-compliant imaging operations with 21 CFR Part 11 controls
- Audit-ready documentation from a GCSA-certified organization
How the prime model works
| Dimension | Amavita Research |
|---|---|
| Contracting | Amavita is the prime contractor to the sponsor. Cardiac PET imaging executes as a qualified subcontracted workstream — no direct sponsor-to-imaging-vendor contracting. |
| Accountability | One project manager owns feasibility, budget, imaging reads, and monitor access. Enrollment and treatment run under one PI team at our North Miami Beach site. |
| Imaging delivery | Cardiac PET delivered through our qualified imaging network — PET/CT acquisition, tracer coordination, per-charter reads, DICOM transfer and QC. |
| Patient enrollment | Cardiovascular enrollment happens at our North Miami Beach site: heart failure, hypertension, ACS, structural heart, and peripheral artery disease. |
| Quality | GCSA-certified through February 2027. GCP and 21 CFR Part 11 controls on imaging data. Zero FDA Form 483 findings to date. |
Frequently asked questions
Does Amavita own PET scanners?
No. Amavita is a clinical trial site and PET imaging trial partner — cardiac PET imaging is delivered through our qualified imaging network under Amavita's oversight, with per-charter reads, DICOM transfer and QC, and 21 CFR Part 11 controls.
Can Amavita run first-in-human cardiac tracer studies?
Yes. We run cardiovascular radiopharmaceutical studies end to end, from first-in-human healthy-volunteer PET studies through later-phase trials — PET imaging, PK blood sampling, dosimetry support, and standard safety assessments.
Which cardiac PET tracers can you support?
Myocardial perfusion PET, cardiac amyloidosis, and vascular inflammation tracers, including 18F-labeled agents, coordinated through our qualified imaging network per the study imaging charter.
Do you produce PET tracers on-site?
Yes — through our qualified imaging partner at MedSquare Health, N-13 ammonia for cardiac PET is produced on-site: the only program of its kind in the Miami market. N-13's 10-minute half-life means it must be produced minutes before injection, which is why on-site production is a radiopharmacy capability no other Miami site can offer.
How fast can we start?
Our last program went from CTA to first-patient-in in 41 days. We target contract turnaround in days, not quarters, and Nereisy Alonso, COO, leads a 20-minute feasibility consultation for sponsors.
Who owns the sponsor relationship?
Amavita does. Sponsor consultations, feasibility, and operational follow-through are owned by Nereisy Alonso, COO. One contact, same-business-day response.
Next step
Schedule a 20-minute feasibility call
Talk with Nereisy Alonso, COO — she owns all sponsor consultations. Feasibility, budget, contracts, and monitor access from a single owner, with same-business-day response.