Displacement Distance and Stabilization Time for Liver Fiducial Marker

• Sponsor: Peking University Third Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05816837
• Collaborator: (none)
• Enrollment: 30
• Locations: 2
• Anticipated Duration (Months): 24
• Patients Per Site: 15
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

1. B.K. Chang, R.D. Timmerman, Stereotactic body radiation therapy: a comprehensive review, Am J Clin Oncol 30 (6) (2007) 637-644.

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.

3. D.K. Bhasin, S.S. Rana, S. Jahagirdar, B. Nagi, Does the pancreas move with respiration? J Gastroenterol Hepatol 21 (9) (2006) 1424-1427.

4. 1. 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. 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. 1. 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.
7. 1. Valentine, T. Cabrera, D. Roberge, Implanting metal fiducials to guide stereotactic liver radiation: McGill experience and review of current devices, techniques and complications, Technol Cancer Res Treat 13 (3) (2014) 253-258.

Condition or Disease	Intervention/Treatment	Phase
Liver Cancer

Study Design

• Study Type: Observational
• Anticipated Enrollment: 30 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Displacement Distance and Stabilization Time for Liver Fiducial Marker
• Actual Study Start Date: Apr 20, 2022
• Anticipated Primary Completion Date: Apr 19, 2024
• Anticipated Study Completion Date: Apr 19, 2024

Outcome Measures

Primary Outcome Measures

1. Displacement distance [Within 1 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Ages 18 to 85

2. Single or multiple liver tumors or mass (solid, partially solid)

3. 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)

4. KPS>60 points, no serious or uncontrolled underlying diseases, clinical evaluation patients can tolerate puncture

5. Planned fiducial marker implantation with applicable puncture path

6. With informed consent.

Exclusion Criteria:

1. Poor organ function

2. 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

3. Poor compliance, unable to complete coordination

4. Paticipant who is considered inappropriate or unwilling to participate in this clinical trial for other reasons.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University Third Hospital	Beijing	United Kingdom Of Great Britain And Northern Ireland	China	100010
2	Department of Radiation Oncology of Peking university third hospital	Beijing		China

Sponsors and Collaborators

• Peking University Third Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Qiu Bin, Principal Investigator, Peking University Third Hospital
• ClinicalTrials.gov Identifier: NCT05816837
• Other Study ID Numbers: 3D-LVFM-1
• First Posted: Apr 18, 2023
• Last Update Posted: Apr 18, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Qiu Bin, Principal Investigator, Peking University Third Hospital: liver cancer
• Additional relevant MeSH terms: Liver Neoplasms

Study Results

No Results Posted as of Apr 18, 2023