Lugano gives you categories. MTV gives you the data to defend a Phase III decision — or stop before it's too late. Quantitative PET analysis for oncology sponsors who can't afford ambiguity.
Clinical Context
Standard reads can't tell progressive disease from partial response. MTV distinguishes them when standard Lugano alone cannot — and your Phase III go/no-go depends on knowing the difference.
AmbiguityInvestors and regulators now expect MTV-backed efficacy claims. Without volumetric data, you'll re-litigate every response category in FDA review — on their timeline, not yours.
RegulatoryICML-17 (2025) is making MTV mandatory — yet most CROs still treat it as a side service billed mid-trial. Volumetryx includes it as standard, not a scope-change conversation.
Hidden CostSupported Criteria
Analysis Parameters
Automated volumetric delineation with manual adjudication by a lymphoma-trained radiologist. All lesion ROIs are transferred across timepoints for consistent longitudinal tracking.
Full-Stack Imaging
Automated injection-to-scan timing verification, SUV calibration checks, and scanner harmonization QA. Every PET study validated before it enters the read queue — preventing late-stage rejects that delay database lock.
tMTV, TLG, ΔtMTV, and SUV metrics delivered in the BioSUITE dashboard — not a separate engagement, not an invoice line item six weeks in. Results are interactive, exportable, and available 24–72h after image receipt.
Dual-reader Lugano and LYRIC assessments by lymphoma-trained radiologists. Discordant Deauville cases — particularly D4 ambiguity — go to adjudication without sponsor intervention. Full audit trail for 21 CFR Part 11 compliance.
Why Volumetryx
tMTV, TLG, and ΔtMTV in every lymphoma engagement — no surprises, no scope-change conversations mid-trial.
Decision-critical data when the decision is being made — not batched quarterly.
Raw values in CSV/JSON at any point. No data hostage situations at contract renewal.
Dedicated experience across DLBCL, Hodgkin, T-cell, and rare subtypes — not generalists on rotation.
Use Case
Mid-trial interim analysis. LUGANO reads are in: 40% CR, 25% PR, 20% SD, 15% PD. Board has a go/no-go meeting in 10 days for a Phase III commitment worth $40M. The SD cohort is the question mark — are they non-responders, or late responders who haven't metabolically converted yet?
Without MTV data, the answer is a shrug. With Volumetryx, the CMO opens BioSUITE at the board meeting: patients with >50% tMTV reduction at Week 12 show 85% 12-month PFS. SD patients show tMTV trending down — metabolic burden actively shrinking, morphologic response lagging. Late responders, not failures.
The board decides in one meeting. The Phase III decision gets made with confidence. The data package goes to the lead investor the same week. Enrollment continues.
Go/no-go decision made in one meeting instead of waiting 3 weeks for iCRO analysis. $40M Phase III commitment secured on time. Trial on track.
Tell us your trial design and current imaging protocol. We'll define the right quantitative endpoints for your lymphoma indication.