4th LDCT Mega Trial / LIFEMAP Study Design Meeting SCCT.26 - San Diego

Thursday, July 9, 2026 | 2:00-3:00 PM PST LDCT Mega Trial - Preventive Imaging Agentic AI vs Usual CareLIFEMAP Research Group

Meeting Objective: To review recent AI-CVD and Agatston-2.0 research progress, discuss the latest LDCT Mega Trial / LIFEMAP study design, evaluate key unresolved protocol questions, introduce LUNGevity as a potential nonprofit administrative and advocacy partner, and begin discussion of funding sources and fundraising plans.

1. Opening Remarks

Dr. Morteza Naghavi

Dr. Arthur Agatston

2:00-2:10 PM

• Welcome and purpose of the 4th LDCT Mega Trial Design Meeting

• Brief recap of the LDCT Mega Trial / LIFEMAP vision

• Framing the trial as a large-scale, pragmatic randomized study of preventive imaging agentic AI versus usual care

• Goal of this meeting: move toward final study design, governance structure, administrative platform, and fundraising strategy

2. HeartLung.AI Research Fellows: Trial-Relevant CVD and Lung Cancer Research Updates

Six presentations, 5 minutes each

2:05-2:35 PM

AI-CVD Research Update on

	Dr. Hamed Zarei   Agatston-2.0 in CAC-zero and CAC-1-99 populations Agatston 2.0 SCCT
	Dr. Reza Mirjalili   CAC scan-based, AI-enabled prediction of ASCVD, HF, AF & Stroke AI-CVD Presentation
	Dr. Amir Ghaffari CAC scan-based, AI-enabled coronary plaque analysis and Virtual CCTA AI-CAC Coronary Plaque Analysis
	Dr. Mohammad Mozaffary   AI-enabled opportunistic lung cancer screening and prediction AutoLung Intorduction SCCT
	Dr. Zahra Heidari  Agentic AI for preventive medicine in 2030 and beyond Vision 2030 and beyond

Each presentation briefly addresses AI-enabled CT biomarkers for risk phenotyping, and care pathways in the trial.

3. Questions on AI-CVD Updates and Transition to Study Design

Moderated by Dr. Naghavi

2:35-2:42 PM

• Clarifying questions from the group

• Relevance of AI-CVD findings to the trial intervention arm

• How AI-derived imaging biomarkers can support multi-disease prevention from a single LDCT scan

4. Latest LDCT Mega Trial / LIFEMAP Study Design

2:42-2:52 PM

Brief presentation of the current proposed study design:

• Target population and eligibility criteria

• Randomization: usual care versus LIFEMAP preventive imaging agentic AI

• Baseline LDCT plus AI phenotyping in the intervention arm

• AI-guided personalized prevention plan with physician approval gate

• Proposed follow-up duration and outcome ascertainment

• Primary endpoint options: all-cause mortality, MACE, late-stage lung cancer, COPD hospitalization, fragility fracture, and cost-effectiveness

• Secondary endpoints: LDL-C reduction, BP control, statin initiation, nodule follow-up adherence, DXA referral, healthcare utilization, QALYs, productivity, equity, and quality of life

• Pilot phase concept: feasibility validation before full-scale 100,000-person enrollment

• Go/No-Go criteria before mega-trial launch: technical performance, EHR integration, physician workflow, patient acceptance, safety, and operational readiness

5. Open Discussion: Final Study Design Questions

All participants

2:52-3:05 PM

Key discussion questions:

• Trial Steering Committee

• Should the trial have disease-domain co-leads for lung cancer, CVD, COPD, metabolic/liver disease, bone/body composition, health economics, and equity?

• What should be the final primary endpoint hierarchy?

• Should the trial use multiple co-primary endpoints, or should it prioritize one primary composite with key secondary endpoints?

• What is the minimum AI-CVD / LDCT biomarker panel required for the intervention arm?

• Should the pilot phase include 500 or 1,000 participants?

• What Go/No-Go criteria should be mandatory before launching the full mega trial?

• How should downstream care pathways be standardized while preserving physician judgment and avoiding unnecessary testing?

• How should safety, AI-attributed adverse events, equity monitoring, model governance, and clinical events adjudication be structured?

6. LUNGevity Overview and Potential Role

Andrea Ferris, President and CEO, LUNGevity

3:05-3:18 PM

Suggested focus:

• Overview of LUNGevity’s mission, programs, infrastructure, and early lung cancer initiatives

• Experience in research support, patient advocacy, screening awareness, policy, community engagement, and health equity

• Potential fit as a nonprofit administrative, advocacy, patient-engagement, and fundraising partner for the LDCT Mega Trial

• LUNGevity’s perspective on what would be needed to evaluate partnership feasibility

• Potential operating models: administrative partner, fiscal sponsor, co-sponsor, patient-advocacy partner, fundraising partner, or broader nonprofit trial platform

7. Trial Administration, Governance, and Nonprofit Structure

Group discussion

3:18-3:28 PM

Topics:

• Role of LUNGevity relative to academic PI institutions, imaging cores, data coordinating centers, and the scientific steering committee

• Trial administration needs: contracts, donor management, site coordination, patient/community engagement, communications, policy outreach, and reporting

• Governance structure: Steering Committee, Executive Committee, Scientific Advisory Committee, DSMB, Clinical Events Committee, Equity Committee, and Fundraising Committee

• Conflict-of-interest management and preservation of scientific independence

• Public-domain principles for study design, data governance, and publication strategy

8. Funding Sources and Fundraising Plan

Group discussion

3:28-3:40 PM

Discussion points:

• Philanthropic funding strategy

• Federal, foundation, and public-private funding opportunities

• High-net-worth donor and family foundation outreach

• Industry participation with appropriate safeguards

• Disease-domain funding pillars: lung cancer, CVD, COPD, osteoporosis/fracture prevention, metabolic/liver disease, health equity, and AI-enabled prevention

• Near-term funding needs: protocol finalization, pilot phase, data coordinating center, site planning, regulatory/ethics preparation, and donor-facing materials

• Materials needed: executive summary, study-design synopsis, budget, slide deck, governance plan, and philanthropic case statement

9. Action Items and Next Steps

Dr. Naghavi

3:40-3:45 PM

Proposed next steps:

• Identify provisional PI/co-PI structure

• Circulate revised study-design summary after the meeting

• Define LUNGevity’s potential role and next due-diligence questions

• Establish a small governance and administration working group

• Establish a fundraising working group

• Refine the pilot phase and Go/No-Go criteria

• Prepare donor-facing materials

• Schedule the next LDCT Mega Trial / LIFEMAP planning meeting

Expected Meeting Outcomes

By the end of the meeting, the group will align on:

1. The current LDCT Mega Trial / LIFEMAP study-design framework

2. The key unresolved protocol questions before finalization

3. The provisional Steering Committee and disease-domain leadership structure

4. The pilot phase and Go/No-Go concept

5. The safety, governance, equity, and AI model oversight framework

6. LUNGevity’s potential role as a nonprofit administrative, advocacy, and fundraising partner

7. Initial funding sources and fundraising priorities

8. Concrete next steps before the next meeting at ASPC.26 in Pheonix AZ