MicroEnvironment Tumor Effects of Radiotherapy - Comprehensive Radiobiology Assessment TRial (METEOR-CRATR)

The Washington University

Status: Enrolling

Conditions: Locally Advanced Cervical Carcinoma; Locally Advanced Pancreatic Cancer; Cancer of the Cervix; Locally Advanced Pancreas Cancer; Pancreas Cancer; Locally Advanced Cervical Cancer; Cancer of the Pancreas; Cervical Cancer; Locally Advanced Pancreatic Carcinoma; Pancreatic Cancer

Treatments: Other: Tumor collection via biopsy; Device: Diffusion basis spectrum imaging (DBSI) magnetic resonance imaging (MRI); Other: Blood collection

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05975593

202307103

U54CA274318 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study is a dynamically adjustable prospective longitudinal study designed to capture biospecimen (biopsy, blood, surgical) and multimodal treatment-related data (imaging, dosimetry, clinical) before, during, and after treatment with definitive-intent chemoradiotherapy for patients with locally advanced cervical and pancreatic cancer.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmation of intent to receive radiotherapy for one of the following diagnoses:

  • Cervical cancer
  • Pancreatic cancer

• ECOG performance status ≤ 2

• At least 18 years old

• Able to understand and willing to sign an IRB-approved written informed consent document

Exclusion criteria

• Any issue (medical, anatomic, other) that might preclude safe acquisition of biospecimens at the discretion of the treating physician

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Cervical Cancer

Other group

Description:

* Patients will have blood and tumor collected at various time points throughout participation in the study. * Patients will have standard of care imaging obtained at various time points and a diffusion basis spectrum imaging (DBSI) MRI will be obtained at the end of standard of care MRI.

Treatment:

Other: Blood collection

Device: Diffusion basis spectrum imaging (DBSI) magnetic resonance imaging (MRI)

Other: Tumor collection via biopsy

Pancreatic Cancer

Other group

Description:

* Patients will have blood and tumor collected at various time points throughout participation in the study. * Patients will have standard of care imaging obtained at various time points and a diffusion basis spectrum imaging (DBSI) MRI will be obtained at the end of standard of care MRI.

Treatment:

Other: Blood collection

Device: Diffusion basis spectrum imaging (DBSI) magnetic resonance imaging (MRI)

Other: Tumor collection via biopsy