MicroEnvironment Tumor Effects of Radiotherapy - Comprehensive Radiobiology Assessment TRial

NCT05975593 — Not applicable, Recruiting, 60 participants, Washington University School of Medicine

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

Registry	NCT05975593, acronym METEOR-CRATR
Status	Recruiting
Phase	Not applicable
Study type	Interventional; non randomized, parallel, masking: none, diagnostic
Enrollment	60 (Estimated)
Sponsor	Washington University School of Medicine (Other); collaborators: National Cancer Institute (NCI), The Foundation for Barnes-Jewish Hospital
Conditions	Locally Advanced Cervical Carcinoma, Locally Advanced Cervical Cancer, Locally Advanced Pancreas Cancer, Locally Advanced Pancreatic Carcinoma, Locally Advanced Pancreatic Cancer, Cervical Cancer, Pancreas Cancer, Pancreatic Cancer, Cancer of the Cervix, Cancer of the Pancreas
Interventions	Tumor collection via biopsy, Blood collection, Diffusion basis spectrum imaging (DBSI) magnetic resonance imaging (MRI) (Other, device)
Dates	start 2024-01-11, primary completion 2032-12-31 (estimated), completion 2032-12-31 (estimated), first posted 2023-08-04, last updated 2026-08-17
Locations	1 site in United States

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Cervical Cancer	Other	Other: Tumor collection via biopsy; Other: Blood collection; Device: Diffusion basis spectrum imaging (DBSI) magnetic resonance imaging (MRI)	* 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.
Pancreatic Cancer	Other	Other: Tumor collection via biopsy; Other: Blood collection; Device: Diffusion basis spectrum imaging (DBSI) magnetic resonance imaging (MRI)	* 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.

Tumor collection via biopsy (Other): Cervical cancer: Pre-radiation therapy, 1 week after beginning radiation therapy, 3 weeks after beginning radiation therapy, and recurrence. Pancreatic cancer: pre-stereotactic body radiotherapy, 12 weeks after completion of radiotherapy, and recurrence.
Blood collection (Other): Cervical cancer: pre-radiation therapy, 1 week after beginning radiation therapy, 3 weeks after beginning radiation therapy, 6 weeks after completing radiation therapy, 12 weeks after completing radiation therapy, and recurrence. Pancreatic cancer: pre-stereotactic body radiotherapy, 6 weeks after completion of radiotherapy, 12 weeks after completion of radiotherapy, surgery (if applicable), and recurrence
Diffusion basis spectrum imaging (DBSI) magnetic resonance imaging (MRI) (Device), also known as DBSI MRI: Cervical cancer: initial staging, 12 weeks after completing radiation therapy, and recurrence. Pancreatic cancer: initial staging, stereotactic body radiotherapy (SBRT) simulation, 12 weeks after completing radiation therapy, and recurrence. The imaging will be performed when possible.

+Outcome measures

Primary outcomes

Changes in tumor microenvironment [From start of follow-up through completion of follow-up (estimated to be 5 years)]: Generalized linear mixed effects models will be first used to capture the changes in the longitudinal values of a single assay output over time for a given biospecimen. Random effects will be used to describe the correlation of repeated measures on the same subject over time.

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Washington University School of Medicine	St Louis, Missouri	United States	Recruiting

+Investigators

Michael Waters, M.D., Ph.D., Principal investigator, Washington University School of Medicine

+Funding

NIH grants: U54CA274318