Radiopaque Hydrogel in Patients Undergoing Radiotherapy for Pancreatic Cancer

NCT03307564 | Completed Results DMC FDA Device

• 2 other identifiers: J17144IRB00151816
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Number of Patients Where TraceIT Tissue Marker Placement Achieved

  Measured as number of patients where marking the interface between the pancreas and duodenum with TraceIT Tissue Marker in patients undergoing image-guided radiotherapy for BR/LAPC pancreatic adenocarcinoma was achieved.

  day 1

Study Arms (1)

TraceIT tissue marker injection

EXPERIMENTAL

The TraceIT injection will be performed during the endoscopic fiducial placement which is the standard of care. CTs to serially confirm TraceIT positioning will be performed on the same day during patient visits for their middle (2nd or 3rd fraction) and last (5th fraction) radiation therapy treatments

Device: TraceIT tissue marker injection

Interventions

TraceIT tissue marker injection DEVICE

The TraceIT injection will be performed during the endoscopic fiducial placement which is the standard of care. CTs to serially confirm TraceIT positioning will be performed on the same day during patient visits for their middle (2nd or 3rd fraction) and last (5th fraction) radiation therapy treatments.

TraceIT tissue marker injection

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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): \< 1.5
• Serum pregnancy: Negative
• Hemoglobin: ≥ 8.0 g/dl
• Zubrod Performance Status 0-2
• Subject or authorized representative, has been informed of the nature of the study and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) of the respective clinical site.

You may not qualify if:

• Previous thoracic radiotherapy
• Any GI (gastrointestinal) abnormality that would interfere with the ability to access the injection site
• Active gastroduodenal ulcer or watery diarrhea
• Active bleeding disorder or a clinically significant coagulopathy defined as a PTT (Partial thromboplastin time) \>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) \<4000/uL or \>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

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Augmenix, Inc.: collaborator

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Results Point of Contact

• Title: Amol Narang. MD
• Organization: SKCCC @ Johns Hopkins

anarang2@jhmi.edu

410-955-7390

Study Officials

• Amol Narang, MD

  Johns Hopkins SKCCC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: marking the interface between the pancreas and duodenum with TraceIT Tissue Marker in patients undergoing image-guided radiotherapy

Study Record Dates

• First Submitted: October 5, 2017
• First Posted: October 11, 2017
• Study Start: June 6, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: April 25, 2024
• Results First Posted: December 21, 2022

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)