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Head and Neck NeoplasmsNCT05396183

Accuracy and Safety of Coplanar Template Assistance for Head and Neck Biopsies.

An observational study of Head and Neck Neoplasms, run by Peking University Third Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a prospective single-arm cohort study to evaluate the accuracy and safety of three-dimensional printing co-planer template(3D-PCT) for computed tomography (CT)-guided neck and head biopsy . Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Head and Neck Neoplasms
How many people
30 participants
Where
1 siteChina
Study dates
25 May 2022to 25 Mar 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Consecutive eligible patient with head and neck masses or nodules, who are planned undergo biopsy with applicable puncture path in Peking university Third hospital will be enrolled.

Who may be able to join

  • 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.

Who cannot join

  • (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.

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting
  • Department of Radiation Oncology of Peking university third hospital

    Beijing, Beijing Municipality, 10010

    Bin Qiu, MD, 01082265968, 542122203@qq.com

    Recruiting

Other trials in China

About this study

Official title: A Prospective Single-arm Cohort Study on Accuracy and Safety of Coplanar Template Assisted CT-guided Neck and Head Biopsies.

This is a prospective single-arm cohort study to evaluate the accuracy and safety of three-dimensional printing co-planer template(3D-PCT) for computed tomography (CT)-guided neck and head biopsy .

Read the detailed description

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.

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
Keywords
Head and Neck Neoplasms, biopsy, 3D-PCT
Medical subject headings
Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05396183
Study groupRoleWhat they receive
3D-PCT groupParticipant 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Accuracy

    Depth and Angle difference between actual puncture and planned puncture pathway.

    Measured: During the operation.

Secondary outcomes (2)
  1. Complication rate

    Adverse event include needle track implantation metastasis and operation-related complications (e.g. bleeding, nerve injury, air embolism).

    Measured: During the first month after operation.

  2. Pathological Diagnosis

    The pathological diagnosis of head and neck biopsy.

    Measured: During the first month after operation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2022
  2. Study start25 May 2022 (estimated)
  3. Primary completion25 Feb 2024 (estimated)
  4. Study completion25 Mar 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05396183
Sponsor's protocol ID
ChiECRCT20220052
Status last verified
May 2022
First submitted
25 May 2022
Last updated
31 May 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Head and Neck Neoplasms, run by Peking University Third Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Bin Qiu, MD (010-82265968, 15269757106@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Accuracy (time frame: During the operation.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2022.

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