When MTV
Determines
Kill or Keep

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.

Baseline
Week 12
tMTV (cc)
288
−98.6% reduction
TLG
1377
−99.0% reduction
SUVmax
14.3
−53.1% reduction
SUVpeak
11.8
−58.5% reduction
FDA 21 CFR Part 11 HIPAA GDPR PIPEDA AWS

Clinical Context

The Clinical Challenges in Lymphoma Trials

Challenge 01

Deauville 5 hides PD vs PR.

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.

Ambiguity
Challenge 02

CR rates leave Phase III on shaky ground.

Investors 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.

Regulatory
Challenge 03

CROs bill MTV as a $500K add-on.

ICML-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 Cost

Supported Criteria

Supported Response Criteria

Metabolic (PET)
Lugano
Standard for DLBCL, Hodgkin, and most B-cell lymphomas. Deauville 5-point scale with MTV quantification overlay.
LYRIC
Lymphoma Response to Immunomodulatory Therapy Criteria — handles pseudoprogression in CAR-T and checkpoint inhibitor trials.
RECIL
Response Evaluation Criteria in Lymphoma — simplified 3-target bidimensional measurement for streamlined reads.
Morphologic (CT)
RECIST 1.1
Unidimensional longest-diameter measurements. Used when morphologic data is the primary or co-primary endpoint, or required by sponsor protocol.
Combined
PET/CT integrated reads — metabolic + morphologic data reported together in a single dashboard view per timepoint.

Analysis Parameters

What We Measure in Lymphoma

tMTV
Total metabolically active tumor burden — strongest independent prognostic factor in DLBCL and Hodgkin lymphoma.
Primary
TLG
MTV × SUVmean — captures both volume and metabolic intensity; more sensitive to early response than SUVmax alone.
Sensitive
ΔtMTV Wk12
Interim MTV change — distinguishes true responders from late responders when Lugano alone is ambiguous at mid-cycle.
Interim
SUVmax
Maximum standardized uptake — Deauville-based tracking across all timepoints with automated comparison to liver reference.
Tracking
ΔSUVmax
Percentage change in maximum uptake from baseline — tracks individual lesion-level response when global MTV shifts are expected.
Tracking
Baseline
tMTV 288 cc

3D MTV Segmentation — DLBCL Patient

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

Full-Stack Lymphoma Imaging

BioSUITE Platform

PET QA: SUV Calibration + Timing

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.

Advanced Analysis

MTV/TLG Core Service, Not an Add-On

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.

Central Read

Lugano + LYRIC Reads with Adjudication

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

Why Sponsors Choose Volumetryx for Lymphoma

$0
MTV add-on cost

MTV included, not a $500K add-on

tMTV, TLG, and ΔtMTV in every lymphoma engagement — no surprises, no scope-change conversations mid-trial.

72h
Read turnaround

24–72h reads vs. 2–4 week batches

Decision-critical data when the decision is being made — not batched quarterly.

100%
Data ownership

Export tMTV/TLG anytime

Raw values in CSV/JSON at any point. No data hostage situations at contract renewal.

10,000+
Cases read

Lymphoma-trained readers

Dedicated experience across DLBCL, Hodgkin, T-cell, and rare subtypes — not generalists on rotation.

Use Case

DLBCL Kill/Keep Decision

Series B Biotech — Phase II CAR-T — Relapsed DLBCL

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.

Outcome

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.

Trial Phase
Phase II
CAR-T — Relapsed/Refractory DLBCL
LUGANO Distribution
40% CR
25% PR · 20% SD · 15% PD — ambiguous picture without MTV
MTV-Based Decision Speed
1 meeting
vs. 3 weeks for external iCRO analysis
Phase III Stake
$40M
Commitment secured with MTV + TLG data in dashboard

MTV data in
your next board meeting.

Tell us your trial design and current imaging protocol. We'll define the right quantitative endpoints for your lymphoma indication.

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