Hyperpolarized 13C-MRI and Radiomics in Rectal Cancer

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20+
SponsorChang Gung Memorial Hospital

About this trial

This study is testing new imaging and analysis methods to improve how doctors predict treatment response in rectal cancer patients receiving chemoradiotherapy. Current MRI scans sometimes miss complete tumor response, which can lead to unnecessary surgery. To address this, researchers will use a special MRI technique called hyperpolarized carbon-13 MRI, along with blood and tissue analysis (metabolomics) and advanced image feature analysis (radiomics). These tools can track how cancer cells use energy and how metabolism changes during treatment.

The study will follow 30 rectal cancer patients at Chang Gung Memorial Hospital over 3 years. Patients will undergo standard MRI, colonoscopy, and advanced metabolic imaging before and after treatment. Results will compare patients whose tumors completely respond to therapy with those who do not. The goal is to see if metabolic changes detected by hyperpolarized MRI and metabolomics can predict treatment outcomes earlier and more accurately. This may help doctors avoid unnecessary surgery and provide more personalized care for rectal cancer patients.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients with biopsy proved rectal adenocarcinoma.

Patents will undergo neoadjuvant chemoradiation therapy (nCRT).

Patients more than 20-year-old.

Disqualifiers

None

Trial population

The study population consists of patients with rectal cancer who received neoadjuvant chemoradiotherapy (nCRT) at a single center. Eligible participants are adults diagnosed with rectal cancer and treated with nCRT prior to surgery.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Hyperpolarized 13C-MRI (HP 13C-MRI)

    Drug

    Metabolic MRI using IV injection of hyperpolarized \[1-13C\]pyruvate.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Pathological Complete Response (pCR)1 intervention
Group B: Non-Complete Response (non-pCR)1 intervention

Trial outcomes

Primary outcomes

1

Metabolic activity in spleen measured as pyruvate-to-lactate conversion rate

The pyruvate-to-lactate conversion calculated by kinetic modeling-based conversion rate of pyruvate-to-lactate (kPL) and model-free metric (signal-to-noise ratio and area-under-curve).

Time frame
Data analysis within 7 days after HP 13C-MRI

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chang Gung Memorial Hospital

Lead sponsor

Ministry of Science and Technology, Taiwan

Collaborator