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

ConditionUpper Abdominal Malignancies
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pittsburgh

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Had prior Radiation Therapy to the liver

Contraindication to receipt of iodinated IV contrast for CT (such as renal insufficiency or allergy that cannot be overcome by premedication)

Pregnancy/lactation OR woman of childbearing potential who is unable or unwilling to use adequate contraception during Radiation Therapy.

Inability to fast.

Trial design

Design model

Single group

Treatments tested in this trial

  • Standardized high-carbohydrate meal

    Dietary supplement

    8 ounces of Ensure® nutritional protein shake or a similar meal

Treatment groups

17 Participants
are divided into 1 treatment group
Group A: High Carbohydrate DietExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Diurnal Difference in Liver Volumes

Percentage diurnal difference in total liver volumes (change in liver volume), as measured by Stereotactic Body Radiation Therapy (SBRT) planning software.

Time frame
At baseline and at 4 hours post intervention

Secondary outcomes

1

Difference in total liver volume

Percentage difference in total liver volume (measured by Stereotactic Body Radiation Therapy (SBRT) planning software) after standardized high-carb meal (intervention).

Time frame
At baseline and at 1 hour post intervention
2

Percentage diurnal difference in liver mean dose at V5 Gy

Percentage diurnal difference in liver mean dose at V5 Gy (measured by Stereotactic Body Radiation Therapy (SBRT) planning software) after standardized high-carb meal (intervention).

Time frame
At baseline and at 1 hour post intervention
3

Percentage diurnal difference in liver mean dose at V15Gy

Percentage diurnal difference in liver mean dose at V15 Gy (measured by Stereotactic Body Radiation Therapy (SBRT) planning software) after standardized high-carb meal (intervention).

Time frame
At baseline and at 1 hour post intervention
4

Difference in liver mean dose at V15 Gy

Percentage difference in liver mean dose, V5 Gy (measured by Stereotactic Body Radiation Therapy (SBRT) planning software) after standardized high-carb meal (intervention).

Time frame
At baseline and at 1 hour post intervention

Other outcomes

Sponsors and contacts

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

University of Pittsburgh

Lead sponsor

American College of Radiation Oncology

Collaborator

Source ClinicalTrials.gov
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