Liver Volume Variation Effect on SBRT Planning and Delivery for Upper Abdominal Malignancies

Conditions

• Upper Abdominal Malignancies

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Standardized high-carbohydrate meal — DIETARY_SUPPLEMENT
  8 ounces of Ensure® nutritional protein shake or a similar meal

Study Details

Standard planning constraints for liver SBRT incorporate strict dose-volume limits for normal liver parenchyma to minimize the risk of radiation-induced liver disease. The presence of diurnal and fasting/fed variations in liver volume therefore carry substantial potential for introducing errors into estimates of dose-volume distribution within normal liver tissue, as well as affecting day-to-day setup fidelity and organ alignment for treatment. This prospective study will examine how diurnal and fast-fed variations in liver volume affect treatment planning for abdominal SBRT.

Key Dates

Start date

May 16, 2024

Status verified

Jun 2026

Primary completion

Mar 31, 2028

Completion

Mar 31, 2028

Study Design

Enrollment

17 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

HEALTH_SERVICES_RESEARCH

Arms

• Experimental: High Carbohydrate Diet
  1. First scan: after an overnight fast of at least 8 hours using standard radiation oncology CT scan with contrast for treatment planning. 2. Standardized high-carb meal such as 8 ounces of Ensure® nutritional protein shake or a similar meal, immediately following first scan and consumed within 15 minutes. 3. Second scan: within 1 hour of ingestion of the high-carb meal using similar settings to those used in the first scan except for contrast use. 4. Third CT scan at least 4 hours (but no more than 5 hours) after ingestion of high-carb diet on the same day utilizing same set up used in first scan with exception for the use of contrast.

Primary Outcome Measure

Diurnal Difference in Liver Volumes [ Time Frame: At baseline and at 4 hours post intervention ]

Central Contacts

• Samantha Demko, BSN
  412-623-1400
  [email protected]
• Brieanna Marino, MS
  412-647-8258
  [email protected]

Locations (1)

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