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NCT03307564

Radiopaque Hydrogel in Patients Undergoing Radiotherapy for Pancreatic Cancer

Completed NA Results posted Last updated 25 April 2024
What this trial tests

NA trial testing TraceIT tissue marker injection in Pancreatic Adenocarcinoma in 6 participants. Completed in 31 December 2022.

Timeline
6 June 2018
Primary endpoint
31 December 2021
31 December 2022

Quick facts

Lead sponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment6
Start date6 June 2018
Primary completion31 December 2021
Estimated completion31 December 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — full company profile →

Who can join

Adults 18 to 100, any sex, with Pancreatic Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Patients Where TraceIT Tissue Marker Placement Achieved Primary · day 1

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.

GroupValue95% CI
TraceIT Tissue Marker Injection6

Adverse events — posted to ClinicalTrials.gov

Time frame: immediate post-procedure period (approximately 3 hours after injection of hydrogel while patients in recovery/observation). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

TraceIT Tissue Marker Injection
Serious: 1/6 (17%)
Deaths: 0/6

Serious adverse events (1 terms)

ReactionSystemTraceIT Tissue Marker Inje…
nauseaGastrointestinal disorders

Most-reported serious reactions: nausea.

Data from ClinicalTrials.gov NCT03307564 adverse events section.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Translational Applications of Hydrogels.
    Correa S, Grosskopf AK, Lopez Hernandez H, Chan D, et al · · 2021 · cited 575× · PMID 33938724 · DOI 10.1021/acs.chemrev.0c01177
  2. Hydrogels in the clinic.
    Mandal A, Clegg JR, Anselmo AC, Mitragotri S. · · 2020 · cited 265× · PMID 32440563 · DOI 10.1002/btm2.10158
  3. Current and Future Prospective of Injectable Hydrogels-Design Challenges and Limitations.
    Almawash S, Osman SK, Mustafa G, El Hamd MA. · · 2022 · cited 79× · PMID 35337169 · DOI 10.3390/ph15030371
  4. Biomedical Application, Patent Repository, Clinical Trial and Regulatory Updates on Hydrogel: An Extensive Review.
    Mohapatra S, Mirza MA, Hilles AR, Zakir F, et al · · 2021 · cited 50× · PMID 34842705 · DOI 10.3390/gels7040207
  5. Evaluation of a Novel Absorbable Radiopaque Hydrogel in Patients Undergoing Image Guided Radiation Therapy for Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma.
    Rao AD, Shin EJ, Meyer J, Thompson EL, et al · · 2020 · cited 16× · PMID 32151732 · DOI 10.1016/j.prro.2020.01.013
  6. Next-Generation 3D Scaffolds for Nano-Based Chemotherapeutics Delivery and Cancer Treatment.
    Shahriar SMS, Andrabi SM, Islam F, An JM, et al · · 2022 · cited 11× · PMID 36559206 · DOI 10.3390/pharmaceutics14122712
  7. Hydrogel Films in Biomedical Applications: Fabrication, Properties and Therapeutic Potential.
    Sutradhar SC, Shin H, Kim W, Jang H. · · 2025 · PMID 41294603 · DOI 10.3390/gels11110918

Verify or expand the search:

Other recruiting trials for Pancreatic Adenocarcinoma

Currently open trials in the same condition.

Other Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins trials

Trials by the same sponsor.

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Data sources for this page

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