Solid Tumor Central Read — RECIST 1.1

Clinical Context

The Clinical Challenges in Solid Tumor Trials

Challenge 01

SD by RECIST — but lesions are cavitating. Are we missing a response?

Longest diameter stays stable while the tumor hollows out. Viable volume may be dropping 40–60% — a signal RECIST cannot capture.

Cavitation

Challenge 02

3 mm change on a 5 cm tumor — SD by RECIST, if the reader catches it at all.

3 mm shrinkage → 65.5 cm³ → 54.4 cm³ (−17% volume). 3 mm growth → 65.5 cm³ → 78.0 cm³ (+19% volume). RECIST rounds off your tumor's biology.

Resolution

Challenge 03

RECIST averages response across lesion sites — masking mixed response.

A shrinking liver met plus a growing lung lesion yields apparent SD. Per-site volumetric mapping shows you which organ system is failing.

Mixed Response

Supported Criteria

Supported Response Criteria

Standard (CT / MRI)

RECIST 1.1

Gold-standard unidimensional measurement for solid tumors. Longest diameter tracking with target and non-target lesion classification.

iRECIST

Immune-modified RECIST for checkpoint inhibitor and immunotherapy trials — handles pseudoprogression with confirmation timepoints.

mRECIST

Modified RECIST for HCC — measures viable (enhancing) tumor rather than overall lesion size. Critical for TACE and locoregional therapy trials.

Immunotherapy / Disease-Specific

irRECIST / irRC

Immune-related response criteria incorporating new lesions into total tumor burden rather than classifying as automatic PD.

WHO + Cheson

Bidimensional measurement criteria and Cheson Revised for trials requiring cross-product assessments or hematologic/solid tumor overlap.

Beyond RECIST

What We Measure in Solid Tumors

Total Volume

3D tumor burden across all target and non-target lesions — captures true disease load that longest diameter misses.

Primary

Viable Volume

Active tumor vs. necrosis separation — critical for cavitating lesions where RECIST shows SD but viable tissue is shrinking 40–60%.

Sensitive

ΔVolume

Volume change between timepoints — distinguishes true response from measurement noise when a 3 mm diameter shift means ±17–19% volume.

Change

Per-Site Map

Organ-level response tracking — reveals mixed response hidden behind aggregate SD when liver mets shrink but lung lesions grow.

Tracking

Renal tumor 3D volumetric segmentation — sagittal view

3D Volumetric Segmentation — Solid Tumor

Viable tumor (red) vs. parenchyma (blue) tracked across sequential slices. Same images as RECIST read — no additional scan required.

Full-Stack Imaging

Full-Stack Solid Tumor Imaging

BioSUITE Platform

CT/MRI QA: Protocol Compliance from Day 1

Automated slice thickness, contrast protocol, and timing verification. Every study validated before it enters the read queue — preventing late-stage rejects that delay database lock.

Central Read

RECIST 1.1 / iRECIST Reads with Adjudication

Independent BICR by solid tumor-trained radiologists. 24–72h turnaround per timepoint, results in BioSUITE dashboard, third-reader adjudication built in. Full audit trail for 21 CFR Part 11.

Advanced Analysis

Volumetric Depth, Not a $500K Add-On

3D tumor volume, viable tissue separation, ΔVolume trending, and per-site response mapping — delivered in BioSUITE, not a separate engagement. Available 24–72h after image receipt.

Why Volumetryx

Why Sponsors Choose Volumetryx for Solid Tumors

Volumetric add-on cost

Volumetric included, not billed separately

3D volume, viable tissue, ΔVolume — in every solid tumor 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 in a summary PDF.

100%

Data ownership

Export per-lesion data anytime

Raw measurements, segmentation files, volumetric data in CSV/JSON. No data hostage situations at contract renewal.

Criteria supported

Every immunotherapy standard covered

RECIST 1.1, iRECIST, irRECIST, irRC, mRECIST — same platform, same team. No criteria gaps, no vendor switching.

Real Decision. Real Stakes.

Use Case: When SD Isn't Stable

Phase II solid tumor trial. RECIST 1.1. Three patients classified as SD at Week 12 — and a protocol decision that hinges on what "stable" actually means.

Phase II Trial CT Imaging RECIST 1.1 3 Patients — SD at Week 12

Standard read, Week 12: Three patients classified as Stable Disease under RECIST 1.1. No change — all three continue on protocol.

Volumetric analysis, same timepoint: Two of the three patients show significant internal necrosis. Viable tumor volume is down 40% from baseline — a meaningful response signal hidden behind a stable longest diameter. The third patient shows the inverse: outer diameter unchanged, but viable volume is increasing. Active tumor is growing inside a stable shell.

Protocol adapted: The sponsor discontinues the third patient, continues the two responders with enhanced monitoring. Without volumetric depth, all three would have followed the same path — two late responders potentially written off, one progressor continuing on treatment that isn't working.

RECIST Alone

All three classified SD.
Same protocol decision.

No differentiation between the two responders and the progressor. Protocol continues unchanged — missing the response signal and the failure signal simultaneously.

Outcome: One progressor continues on treatment. Two responders receive no enhanced monitoring. Missed signal in both directions.

RECIST + Volumetryx

Two responders identified.
One progressor caught early.

Viable volume analysis separates the three patients. The sponsor makes a differentiated protocol decision at Week 12 — without waiting for diameter change to make it obvious at Week 24.

Outcome: Early discontinuation for progressor. Responders identified and continued. Protocol adapted on data, not waiting for RECIST to catch up.

RECIST 1.1.
Plus the depth
it can't give you.

The Clinical Challenges in Solid Tumor Trials

SD by RECIST — but lesions are cavitating. Are we missing a response?

3 mm change on a 5 cm tumor — SD by RECIST, if the reader catches it at all.

RECIST averages response across lesion sites — masking mixed response.

Supported Response Criteria

What We Measure in Solid Tumors

3D Volumetric Segmentation — Solid Tumor

Full-Stack Solid Tumor Imaging

CT/MRI QA: Protocol Compliance from Day 1

RECIST 1.1 / iRECIST Reads with Adjudication

Volumetric Depth, Not a $500K Add-On

Why Sponsors Choose Volumetryx for Solid Tumors

Volumetric included, not billed separately

24–72h reads vs. 2–4 week batches

Export per-lesion data anytime

Every immunotherapy standard covered

Use Case: When SD Isn't Stable

All three classified SD.
Same protocol decision.

Two responders identified.
One progressor caught early.

Get a Quote for Your
Solid Tumor Trial.

RECIST 1.1.Plus the depthit can't give you.

The Clinical Challenges in Solid Tumor Trials

SD by RECIST — but lesions are cavitating. Are we missing a response?

3 mm change on a 5 cm tumor — SD by RECIST, if the reader catches it at all.

RECIST averages response across lesion sites — masking mixed response.

Supported Response Criteria

What We Measure in Solid Tumors

3D Volumetric Segmentation — Solid Tumor

Full-Stack Solid Tumor Imaging

CT/MRI QA: Protocol Compliance from Day 1

RECIST 1.1 / iRECIST Reads with Adjudication

Volumetric Depth, Not a $500K Add-On

Why Sponsors Choose Volumetryx for Solid Tumors

Volumetric included, not billed separately

24–72h reads vs. 2–4 week batches

Export per-lesion data anytime

Every immunotherapy standard covered

Use Case: When SD Isn't Stable

All three classified SD.Same protocol decision.

Two responders identified.One progressor caught early.

Continue exploring the imaging scope for your solid tumor trial.

Get a Quote for YourSolid Tumor Trial.

RECIST 1.1.
Plus the depth
it can't give you.

All three classified SD.
Same protocol decision.

Two responders identified.
One progressor caught early.

Get a Quote for Your
Solid Tumor Trial.