N/A
N=6
Radiopaque Hydrogel in Patients Undergoing Radiotherapy for Pancreatic Cancer
Pancreatic Adenocarcinoma
Bottom Line
View on ClinicalTrials.gov: NCT03307564 ↗Enrolled (actual)
6
Serious AEs
16.7%
Results posted
Dec 2022
Primary outcome: Primary: Number of Patients Where TraceIT Tissue Marker Placement Achieved — 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- TraceIT tissue marker injection (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Where TraceIT Tissue Marker Placement Achieved |
6 | — |
Summary
The goal of this pilot imaging study is to evaluate the visibility of marking the interface between the pancreas and duodenum with TraceIT Tissue Marker. Patients with a pathologically confirmed diagnosis of BR/LAPC (borderline resectable/locally advanced pancreatic cancer) pancreatic adenocarcinomas indicated for neo-adjuvant image-guided radiotherapy with SBRT (stereotactic body radiation therapy) will be enrolled. This study will thus set the stage for further investigations using the TraceIT Tissue Marker to avoid duodenum toxicity with imaging localization, enabling further dose intensification with SBRT or IMRT to improve the clinical outcomes in BR/LAPC.
Eligibility Criteria
Inclusion Criteria
- Age ≥18 years old
- BR/LAPC pancreatic carcinoma disease
- Radiotherapy or chemoradiotherapy for treatment of the disease is indicated with the intent for eventual surgical resection
- Subjects Screening/Baseline laboratory testing must meet the following laboratory value criteria:
- White blood cell count: ≥ 3.0 x 109/L
- Absolute neutrophil count (ANC): ≥ 1.5 x 109/L
- Platelets: ≥ 100 x 109/L
- Total bilirubin: ≤ 2.0 times upper limit of normal (ULN)
- AST (Aspartate Aminotransferase) and ALT (Alanine Aminotransferase): ≤ 3.0 times institutional upper normal limit
- Serum creatinine: 1.5 times ULN (upper limit of normal)
- INR (international normalized ratio): 35s or INR>1.4 or platelet count less than 100,000 per mm3.
- Active inflammatory or infectious process involving the gastrointestinal tract based on positive diagnosis or suspected diagnosis in the presence of fever>38°C or WBC>12,000/uL.
- Compromised immune system: WBC (white blood count) 12,000/uL.
- History of Chronic Renal Failure.
- Documented history of uncontrolled diabetes (i.e., symptomatic hyperglycemia that cannot be medically managed, fasting blood glucose level above 300 mg/dL, and/or frequent swings between hyperglycemia and hypoglycemia)
- Currently enrolled in another investigational drug or device trial that clinically interferes with this study.
- Unable to comply with the study requirements or follow-up schedule.
- Any condition or comorbidity that the Investigator believes would interfere with the intent of the study or would make participation not in the best interest of the subject.
- Pregnancy, breast-feeding, women of child-bearing age must use contraceptives
Data sourced from ClinicalTrials.gov (NCT03307564). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.