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Trial Title:
Displacement Distance and Stabilization Time for Liver Fiducial Marker
NCT ID:
NCT05816837
Condition:
Liver Cancer
Conditions: Official terms:
Liver Neoplasms
Conditions: Keywords:
liver cancer
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
participant with liver tumors and plan to implant fiducial marker for radiatherapy.
Sampling method:
Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University Third Hospital
Address:
City:
Beijing
Zip:
100010
Country:
China
Status:
Recruiting
Contact:
Last name:
Bin Qiu
Phone:
01082265968
Email:
542122203@qq.com
Facility:
Name:
Department of Radiation Oncology of Peking university third hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Bin Qiu
Phone:
01082265968
Email:
542122203@qq.com
Start date:
April 20, 2022
Completion date:
April 19, 2024
Lead sponsor:
Agency:
Peking University Third Hospital
Agency class:
Other
Source:
Peking University Third Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05816837
