Contrast-Enhanced Photon-Counting Detector CT (PCD-CT) for the Local Staging of Rectal Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-07

Study Completion Date

2026-12-31

Brief Summary

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This study evaluates whether images taken using a photon counting detector CT scanner (PCD-CT) can determine the growth of rectal cancer as well as, or better than, MRI for the management of patients with rectal cancer.

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Detailed Description

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Conditions

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Rectal Carcinoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Observational

Patients undergo PCD-CT on study.

PCD-CT

Intervention Type PROCEDURE

Participants undergo PCD-CT scan on study

Interventions

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PCD-CT

Participants undergo PCD-CT scan on study

Intervention Type PROCEDURE

Other Intervention Names

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contrast-enhanced photon-counting detector CT contrast-enhanced photon-counting detector computed tomography

Eligibility Criteria

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Inclusion Criteria

* Adult patients 18 to 99 years of age
* Patients with proven rectal cancer clinically referred for staging pelvic MRI and contrast-enhanced CT of the abdomen and pelvis (for evaluation of liver and peritoneal disease)
* Endoscopic or imaging report that tumor is 2 cm or larger
* Patients who are able and willing to sign the informed consent
* Negative pregnancy test if subject is of child-bearing age (females of child-bearing potential will be screened for pregnancy using a urine pregnancy test, which will be administered by the unit study coordinator at no cost to the patient)

Exclusion Criteria

* Minors less than 18 years old
* Known mucinous adenocarcinoma (may not enhance well)
* Patient unable to provide written informed consent
* Pregnancy
* estimated Glomerular Filtration Rate (eGFR) ≤ 60
* History of prior moderate or severe contrast reaction including unresponsiveness, severe respiratory distress, convulsions, arrhythmia, cardiopulmonary distress, progressive angioedema, laryngeal edema, dyspnea, bronchospasm, symptomatic tachycardia, symptomatic bradycardia, hypotension, hypertensive crisis
* Any history of premedication prior to iodinated contrast
* Hip replacement/prosthesis
* Patients that consent to participation but do not undergo their clinically indicated MRI scanning for any reason (e.g., bad IV, infiltration, reaction, change in indication)

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No