- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05396183
Accuracy and Safety of Coplanar Template Assistance for Head and Neck Biopsies.
A Prospective Single-arm Cohort Study on Accuracy and Safety of Coplanar Template Assisted CT-guided Neck and Head Biopsies.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Tumors in head and neck region refer to those located above the clavicle, the upper boundary is the skull base, the posterior boundary is cervical vertebra, excluding brain spinal cord and other central nervous system and Intraocular tumor. Include oral cavity (lips, tongue, hard palate, floor of mouth, gums), oropharynx (middle of throat behind mouth, including tongue base, tonsils, and soft palate), larynx, hypopharynx (lower throat), paranasal sinuses, nasopharynx, salivary glands (Parotid, submandibular and minor salivary glands), thyroid, skin cancers and metastatic cancers of the head and neck. Tissue sampling of lesions in the head and neck is limited due to the complex regional anatomy, including nerves, vessels, and salivary glands. Computed tomography (CT)-guided percutaneous puncture biopsy is a well-recognized technique that can facilitate histopathological diagnosis and therapeutic planning of head and neck masses, and may be particularly useful when lesions are not accessible via an endoscope or by palpation-guided sampling. CT image-guided free-hand puncture biopsy is widely used in clinical practice. However, multiple CT scan and adjustment of position of the biopsy needle increased radiation exposure and the probability of other adverse events, such as bleeding and nerve injury. Therefore, we need a more efficient approach to guidance which is precisely positioned and safe to operate.
In recent years, we have taken advantage of three-dimensional(3D) printing template to improve the accuracy and safety of puncture related operations, which simplifies the procedure and shortens the procedure duration[3-4]. 3D printing template include co-planar and non co-planar[5]. However, few prospective studies have focused on three-dimensional printing co-planer template(3D-PCT) for CT-guided neck and head biopsy. The purposes of this prospective, single-arm study are to determine the accuracy and safety of CT guided percutaneous head and neck biopsy assisted by 3D-PCT.
- Tu A S, Geyer C A, Mancall A C, et al. The buccal space: A doorway for percutaneous CT-guided biopsy of the parapharyngeal region. Am J Neuroradiol, 1998.19(4):728- 731.
- Esposito M B, Arrington J A, Murtagh F R, et al. Anterior approach for CT-guided biopsy of skull base and parapharyngeal space lesions. J Comput Assist Tomogr, 1996. 20 (5):739-741.
- Ji Z, Jiang Y ,Guo F, et al. Dosimetry verification of radioactive seed implantation for malignant tumor assisted by 3D printing individual templates and CT guidance. Applied Radiation and lsotopes 2017; 124: 68-74.
- Jiang Y, Ji Z , Guo F, et al. Side effects of CT-guided implantation of 125I seeds for recurrent malignant tumors of the head and neck assisted by 3D printing non co-planar template[J]. Radiation Oncology, 2018, 13(1):18.
- W J, Chai S, Wang R, et al. Expert consensus on computed tomography-assisted three-dimensional-printed coplanar template guidance for interstitial permanent radioactive (125) I seed implantation therapy. J Cancer Res Ther 2019; 15: 1430-1434.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiekontakt
- Navn: Bin Qiu, MD
- Telefonnummer: 010-82265968
- E-mail: 15269757106@163.com
Studiesteder
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Beijing
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Beijing, Beijing, Kina, 10010
- Rekruttering
- Department of Radiation Oncology of Peking university third hospital
-
Kontakt:
- Bin Qiu, MD
- Telefonnummer: 01082265968
- E-mail: 542122203@qq.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
(1) Ages 18 to 80; (2) KPS>70 points, an estimated life expectancy of greater than 3 months; (3)Head and neck masses or nodules can be revealed by CT scan, MRI or ultrasonic examination; (4) 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) ; (5) No serious or uncontrolled underlying diseases, clinical evaluation patients can tolerate puncture; (6) Planned biopsy with applicable puncture path; (7) With informed consent.
Exclusion Criteria:
(1)Biopsy needle insertion route impeded by skeletal structures and close to blood vessels which have high risks of puncture bleeding; (2)Poor organ function (e.g. poorly controlled high blood pressure); (3) Any contraindication of percutaneous head and neck biopsy; (4) Poor compliance, unable to complete coordination; (5) Participant who is considered inappropriate or unwilling to participate in this clinical trial for other reasons.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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3D-PCT group
Participant will receive three-dimensional printing co-planar template (3D-PCT) assisted CT-guided head and neck neoplasm biopsy and prospective accuracy and safety data will record.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Accuracy
Tidsramme: During the operation.
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Depth and Angle difference between actual puncture and planned puncture pathway.
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During the operation.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Complication rate
Tidsramme: During the first month after operation.
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Adverse event include needle track implantation metastasis and operation-related complications (e.g.
bleeding, nerve injury, air embolism).
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During the first month after operation.
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Pathological Diagnosis
Tidsramme: During the first month after operation.
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The pathological diagnosis of head and neck biopsy.
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During the first month after operation.
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Procedural duration
Tidsramme: During the operation.
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The length of procedural duration was measured from the time a patient lain on the examining bed of the CT scanner to the time the first CT scan post biopsy.
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During the operation.
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Radiation exposure
Tidsramme: During the operation.
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Numbers of CT scan.
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During the operation.
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Wang Junjie, Peking University Third Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ChiECRCT20220052
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