Displacement Distance and Stabilization Time for Liver Fiducial Marker

NCT05816837 | Unknown

• 1 other identifier: 3D-LVFM-1
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

Liver malignant tumor, including liver cancer and liver metastasis, is common in China \[1\]. Previous studies have shown that cyber-knife stereotactic radiotherapy is effective and safe for locally advanced liver malignancies with improved local tumor control \[2\]. Real-time tumor tracking in cyber-knife stereotactic radiotherapy is currently used as tumors have respiratory movements \[3\]. At present, fiducial marker is used to realize the real-time track of tumor \[4, 5\]. However, the fiducial marker are likely to displacement usually within 7 days after implantation \[4, 6, 7\]. Therefore, simulated CT are delayed 7 days before the fiducial marker stabilization and significantly extend the radiotherapy planning process, increase the risk of tumor progression. As far as we know, there is no prospective study on the specific displacement distance and duration before the fiducial marker stabilization after implantation. Therefore, the purpose of this study was to study the displacement distance and stabilization time before stereotactic radiotherapy for liver malignant tumors guided by 3D printing template-assisted CT.

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2. 2.Kato Y, Kamomae T, Kumagai M, Oie Y, Noguchi Y, Okudaira K, et al. Hybrid 3D T1-weighted gradient-echo sequence for fiducial marker detection and tumor delineation via magnetic resonance imaging in liver stereotactic body radiation therapy. 2022;95:9-15.
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4. 4.N. Kothary, J.J. Heit, J.D. Louie, W.T. Kuo, B.J. Loo, A. Koong, D.T. Chang, D. Hovsepian, D.Y. Sze, L.V. Hofmann, Safety and efficacy of percutaneous fiducial marker implantation for image-guided radiation therapy, J. Vasc. Interv. Radiol. 20 (2) (2009) 235-239.
5. 5.C.G. Trumm, S.M. Häussler, A. Muacevic, R. Stahl, S. Stintzing, P.M. Paprottka, F. Strobl, T.F. Jakobs, M.F. Reiser, R.T. Hoffmann, CT fluoroscopy-guided percutaneous fiducial marker placement for CyberKnife stereotactic radiosurgery: technical results and complications in 222 consecutive procedures, J. Vasc. Interv. Radiol. 25 (5) (2014) 760-768.
6. 6.Y. Seppenwoolde, W. Wunderink, V.S. Wunderink-van, P. Storchi, R.A. Méndez, B.J. Heijmen, Treatment precision of image-guided liver SBRT using implanted fiducial markers depends on marker-tumour distance, Phys. Med. Biol. 56 (17) (2011) 5445-5468.
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Conditions

Liver Cancer

Keywords

liver cancer

Outcome Measures

Primary Outcomes (1)

• Displacement distance

  Fiducial marker displacement distance (millimeter) in the liver after implantation

  Within 1 weeks

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

participant with liver tumors and plan to implant fiducial marker for radiatherapy.

You may qualify if:

• Ages 18 to 85
• Single or multiple liver tumors or mass (solid, partially solid)
• Without taking drugs affecting coagulation and/or platelet aggregation are used; If used, the drug has been discontinued for a sufficient period of time (e.g. 1 week)
• KPS\>60 points, no serious or uncontrolled underlying diseases, clinical evaluation patients can tolerate puncture
• Planned fiducial marker implantation with applicable puncture path
• With informed consent.

You may not qualify if:

• Poor organ function
• The lesion close to blood vessels and intestine, or there is portal vein hypertension and superior vena cava compression, etc., which are expected to have high risks of puncture bleeding and intestinal injury
• Poor compliance, unable to complete coordination
• Paticipant who is considered inappropriate or unwilling to participate in this clinical trial for other reasons.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (2)

Peking University Third Hospital

Beijing, United Kingdom of Great Britain and Northern Ireland, 100010, China

RECRUITING

Department of Radiation Oncology of Peking university third hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 4, 2023
• First Posted: April 18, 2023
• Study Start: April 20, 2022
• Primary Completion: April 19, 2024
• Study Completion: April 19, 2024
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

CN (2)