Clinical trial NCT05816837: Displacement Distance and Stabilization Time for Liver Fiducial Marker
Official title: Displacement Distance and Stabilization Time for Liver Fiducial Marker
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Cancer
Keywords: liver cancer
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: participant with liver tumors and plan to implant fiducial marker for radiatherapy.

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. 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. 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. 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.
7. K. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Displacement distance
timeFrame: Within 1 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: United Kingdom Of Great Britain And Northern Ireland
city: Beijing
country: China
facility: Department of Radiation Oncology of Peking university third hospital
Study officials:
References: