Tempus assay / Advanced pathology 2 / Advanced pathology 1 · Observational Study

Multiparametric MRI as a Non-Invasive Biomarker of the Tumor Microenviroment

ClinicalTrials.gov · August 19, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a registration of a planned observational study, now suspended, that proposed to correlate dynamic contrast-enhanced and diffusion-weighted MRI characteristics with immunotherapy response in early breast cancer. No results are posted in this registry record, and the study's current suspended status means no evidence on the biomarker hypothesis is yet available.

What was studied

Observational. Breast Cancer, Triple-negative Breast Cancer; age from 18 Years. Intervention: Advanced Pathology. n = 10. 1 site: United States.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

No clinical evidence can be drawn from this suspended registration. Clinicians should not make any decisions based on this record until results are posted and analyzed.

Plain-language summary

A suspended observational registry record with no posted results; only study design and planned outcomes are documented, precluding any evidence of effect or clinical utility.

Study design

As stated by the source record.

MethodsCohort model. Prospective time perspective. Primary outcome measures: Correlate dynamic-contrast enhanced MRI characteristics (assessed at Baseline up to about 14 weeks); Correlate diffusion weight imaging MRI characteristics (assessed at Baseline up to about 14 weeks)

DesignObservational

PopulationBreast Cancer, Triple-negative Breast Cancer; age from 18 Years

Sample size10

InterventionAdvanced Pathology

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Estimated enrollment10

Primary outcome measure 1Correlate dynamic-contrast enhanced MRI characteristics, Baseline up to about 14 weeks

Primary outcome measure 2Correlate diffusion weight imaging MRI characteristics, Baseline up to about 14 weeks

Clinical bottom line

No clinical evidence can be drawn from this suspended registration. Clinicians should not make any decisions based on this record until results are posted and analyzed.

Caveats

Study is suspended; no results posted in registry record.
No sample size justification, effect sizes, or outcome data reported.
No details on patient eligibility criteria, immunotherapy regimen, or pathology correlation methods provided.
Observational design without control arm limits causal inference.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

limited

Observational study with no control arm; suspended recruitment limits execution.

Directness

moderate

Directly addresses MRI as biomarker of tumor microenvironment in early breast cancer.

Consistency

insufficient

No results posted; consistency with other evidence cannot be assessed.

Risk of bias

insufficient

Registry record does not describe methods, blinding, or analysis plan in detail.

Sample adequacy

limited

Estimated enrollment of 10 participants is small and study is suspended.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT04803084). This is a study registration, not published results. Lead sponsor: Laura Kennedy. Recruitment status: SUSPENDED. Study type: OBSERVATIONAL. Enrollment: 10 participants (ESTIMATED). Conditions: Breast Cancer, Triple-negative Breast Cancer. Interventions: OTHER: Tempus assay; OTHER: Advanced pathology 1; OTHER: Advanced pathology 2. Primary outcome measures: Correlate dynamic-contrast enhanced MRI characteristics , Baseline up to about 14 weeks; Correlate diffusion weight imaging MRI characteristics , Baseline up to about 14 weeks. Brief summary: This study is looking at how an imaging test could help doctors understand if a patient with early breast cancer will respond to drugs that use the patient's immune system to fight cancer.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Tempus assayAdvanced pathology 2Advanced pathology 1Triple Negative Breast CancerNCT04803084Breast CancerLaura Kennedy