Oncology radiologist reviewing a chest CT with a highlighted lung tumor lesion

Oncology Imaging Core Lab

Our Oncology Imaging division provides specialized medical imaging expertise and comprehensive imaging core lab and imaging CRO services for oncology and immuno-oncology clinical trials across all phases of clinical development. Supported by more than 180 board-certified radiologists focused in oncology, the Oncology Imaging division combines deep subspecialty expertise with extensive clinical trial imaging experience across solid tumors and hematologic malignancies.

Intrinsic Imaging has participated in hundreds of Phase I through IV oncology clinical trials, supporting the evaluation of both safety and efficacy endpoints across a broad spectrum of cancer indications, imaging modalities, therapeutic mechanisms, and study designs.

The Oncology Imaging division provides expertise in blinded independent central review (BICR), adjudication, and standardized tumor response assessment using established and emerging oncology criteria, including RECIST 1.1, iRECIST, mRECIST, Lugano, Cheson, RANO, PERCIST, Choi, PCWG-2, BI-RADS, and other indication- and protocol-specific methodologies. Intrinsic Imaging's oncology capabilities span the complete imaging lifecycle—from protocol and imaging charter development, site qualification and acquisition standardization through image quality control, quantitative analysis, and regulatory-ready data delivery.

Backed by three FDA inspections with zero Form 483 observations and five ISO certifications, our quality-controlled core lab infrastructure protects the integrity of critical oncology endpoints and supports confident clinical and regulatory decision-making.

Tumor measurements are imaging biomarkers, and they drive key oncology endpoints such as objective response rate (ORR) and progression-free survival (PFS). Our readers apply each protocol's response criteria the same way at every timepoint, so these imaging endpoints stay consistent across sites, scanners, and readers.

Oncology Imaging Division Highlights

Extensive experience in providing services in support of oncology and immuno-oncology clinical trials.
180+ board-certified radiologists focused in Oncology.
Participated in hundreds of Phase I through IV Oncology clinical trials for both safety and efficacy.
Expertise includes the full spectrum of oncology and immuno-oncology imaging indications and assessments.
Experts in all Oncology Criteria: BI-RADS, Cheson, Choi, irRC, iRECIST, IWCLL, Lugano, Macdonald, mRECIST, PCWG-2, PERCIST, RANO, RECIST and others.
Modality expertise includes: CT, MRI, PET/CT, SPECT, bone scintigraphy and ultrasound.
Integrated CRF with multiple criteria support.

Blinded Independent Central Review (BICR)

To reduce reader variability and bias in oncology trials, our core lab conducts blinded independent central review with adjudication, performed by board-certified radiologists focused in oncology. Readers are trained and qualified on each protocol's imaging charter, and every review follows standardized methodologies with integrated data capture.

Tumor Response Criteria: RECIST 1.1 and Beyond

From RECIST 1.1 solid-tumor assessments to criteria for immunotherapy (iRECIST, irRC), lymphoma (Lugano, Cheson), neuro-oncology (RANO, Macdonald), prostate cancer (PCWG-2), and metabolic response (PERCIST), our integrated case report forms support multiple criteria within a single study.

Indication-Specific Oncology Imaging and Response Criteria

Our oncology imaging core lab selects the acquisition method, response criteria and independent review design around the tumor type and treatment. The imaging charter defines baseline eligibility, lesion selection, follow-up timing and response rules before central review begins.

Trial setting	Imaging and criteria	Central assessment
Solid tumors	CT and MRI; RECIST 1.1	Target and non-target lesions, new lesions, best response, progression
Immuno-oncology	CT and MRI; iRECIST and immune-response criteria	Unconfirmed and confirmed progression per protocol timing
Lymphoma	FDG PET/CT and CT; Lugano and Deauville five-point scale	Metabolic and anatomic response, nodal and extranodal disease
Neuro-oncology	Contrast-enhanced MRI; RANO and RANO 2.0	Enhancing and non-enhancing disease, clinical and steroid use
Prostate cancer	CT, MRI and bone scintigraphy; PCWG3	Soft-tissue response and bone progression with protocol confirmation
Hepatocellular carcinoma	Multiphase CT and MRI; mRECIST	Viable enhancing tumor rather than total lesion size alone
Gastrointestinal stromal tumors	CT; Choi criteria	Changes in tumor size and attenuation
Metabolic response	FDG PET/CT; PERCIST	Standardized uptake with acquisition and reconstruction controls

Quantitative Imaging Biomarkers and Radiomics

We measure lesion dimensions, tumor volume, diffusion-derived apparent diffusion coefficient (ADC), perfusion and PET uptake for efficacy and exploratory biomarker analyses. Radiomics support includes lesion segmentation, extraction of quantitative image features and reproducibility checks across scanners and acquisition settings. Feature definitions and analysis methods are specified before analysis to limit avoidable bias.

Imaging assessments feed endpoints such as objective response rate, duration of response and progression-free survival. The protocol defines how central imaging results are combined with clinical data; imaging alone does not establish overall survival or patient benefit.

Reader Agreement, Adjudication and Longitudinal Consistency

Readers qualify on the study criteria and representative cases before production reads. Independent reviewers follow a defined longitudinal reading sequence, with blinding rules that control access to treatment assignment, site assessments and other information that could bias interpretation.

We track discrepancies in lesion selection, response category and progression timing. An independent adjudicator resolves disagreements according to the charter. Reader agreement and drift reviews identify where calibration or retraining is needed, while preserving an audit trail of original assessments and adjudicated results.

PET/CT and Multicenter Acquisition Controls

Site instructions specify scan coverage, slice thickness, contrast timing and follow-up consistency. PET controls address uptake time, glucose documentation, scanner calibration and reconstruction. Quality control checks whether each examination is suitable for the intended endpoint and records missing scans, non-evaluable images and site queries.

Guidance for Sponsors

Physician-authored guidance from Intrinsic Imaging on imaging endpoints and trial design.

Guidance for Sponsors · Volume 4, Issue 3 · 2026 Edition

Oncologic Imaging: The Benefits of Diffusion-Weighted MRI

Diffusion-weighted MRI (DWI) was first used to greatest advantage in stroke imaging. Advances in gradients and pulse sequences have since made it a core tool for detecting, characterizing and following malignant lesions in the chest, abdomen and pelvis. Today it is the dominant sequence for peripheral-zone prostate cancer, a foundation of whole-body MRI for bone and marrow disease, and, through the apparent diffusion coefficient (ADC), a quantitative biomarker with published repeatability standards. For sponsors, DWI offers a fast, contrast-free measure of tumor cellularity and treatment response, provided acquisition and analysis are standardized across sites.

Read the article

Guidance for Sponsors · Volume 4, Issue 6 · 2026 Edition

The Challenges of Reducing Lung Cancer Mortality with Screening

Lung cancer remains the leading cause of cancer death in the United States. Two large randomized trials, NLST and NELSON, have shown that low-dose CT (LDCT) screening reduces lung cancer mortality, and U.S. eligibility was broadened in 2021. Yet the challenges that shaped the first edition of this issue remain: false positives, overdiagnosis, radiation, and the biases that can make screening look more effective than it is. Artificial intelligence for nodule detection and characterization adds new opportunity, and new questions that only well-designed trials can answer.

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Guidance for Sponsors · Volume 5, Issue 1 · 2026 Edition

Immunotherapy and Imaging of Metastatic Pancreatic Adenocarcinoma

Pancreatic adenocarcinoma remains one of the most lethal cancers, with a five-year relative survival of 13% and a rising share of U.S. cancer deaths. After a decade in which checkpoint immunotherapy largely failed in this disease, the therapeutic landscape is finally changing: a new first-line chemotherapy regimen has been approved, and in 2026 an oral RAS inhibitor doubled overall survival in a Phase 3 trial of previously treated patients. These advances raise the stakes for imaging. Contrast-enhanced CT, MRI and FDG-PET/CT must deliver staging and response data that are standardized, reproducible and interpretable under the right criteria, including iRECIST when immunotherapy is involved.

Read the article

More guidance: NSCLC Imaging Advances; Brain Tumor Imaging in Trials; CLL Imaging in Clinical Trials; Colorectal Liver Metastases Imaging in Trials; WHO, RECIST, mRECIST and Cheson Criteria

Browse all Guidance for Sponsors →

Featured Case Study

Oncology

Phase III Immunotherapy RECIST and iRECIST

90+ sites in 18 countries
CT, MRI
RECIST 1.1 and iRECIST

Challenge

Immunotherapy trials present a distinctive interpretive challenge: apparent radiographic progression may reflect treatment-related inflammation rather than true tumor growth. The sponsor required central reviewers to distinguish pseudoprogression from genuine disease progression with consistency across more than 90 sites in 18 countries, while applying two response frameworks—RECIST 1.1 and iRECIST—in parallel. Any variability in how unconfirmed progression was identified, confirmed, or dated threatened to distort the trial's efficacy conclusions and invite regulatory scrutiny.

Read the case study

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More Oncology case studies

Frequently Asked Questions

Which response criteria does Intrinsic Imaging support for oncology trials?

We support all major oncology criteria, including RECIST 1.1, iRECIST, mRECIST, irRC, Lugano, Cheson, Choi, RANO, RANO 2.0, Macdonald, PCWG3, PERCIST, IWCLL, BI-RADS and protocol-specific methodologies.

Does Intrinsic Imaging provide blinded independent central review (BICR)?

Yes. Our oncology radiologists conduct blinded independent central review and adjudication under standardized, protocol-specific review methodologies.

Which imaging modalities does the oncology core lab support?

We support CT, MRI, PET/CT, SPECT, bone scintigraphy and ultrasound, including diffusion, perfusion, volumetric and quantitative PET methods, across Phase I through IV studies.

Can a single study employ more than one response framework?

Yes. We configure separate assessments and data fields for each protocol-defined framework, such as RECIST 1.1 and iRECIST, preserving independent response rules and traceable results.

Planning an Oncology trial? Reach out!

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