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Search / Trial NCT05030597

Exploring the Application Value of PET Molecular Imaging Targeting FAP in Oral Squamous Cell Carcinoma

Launched by ZHONGNAN HOSPITAL · Aug 26, 2021

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging technique called PET/CT using a special agent to help diagnose and stage oral squamous cell carcinoma, which is a type of oral cancer. The researchers want to see if this new method, which targets a specific protein related to cancer (called FAP), can provide better information about the cancer compared to standard imaging methods. Additionally, they will look at whether this imaging can help doctors understand how well treatments are working for patients with oral cancer.

To be eligible for the trial, participants should be between 18 and 70 years old and have a strong suspicion of having oral cancer, particularly if they have had a recurrence after previous treatment. Participants will need to agree to take part in the study and sign a consent form. Those who join will undergo imaging tests before and after treatment, allowing researchers to gather important data. It's important to note that individuals who are pregnant or breastfeeding, have certain health conditions, or cannot tolerate lying still during the imaging process may not be able to participate. This trial is currently recruiting participants.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Voluntary participation with signed informed consent;
  • 2. Aged 18\~70 years;
  • 3. Clinically highly suspected oral cancer and recurrence after treatment (Newly diagnosed patients: Scheduled for surgery or neoadjuvant therapy followed by surgery);
  • 4. Ability to complete baseline and follow-up PET/CT (Follow-up FAPI PET/CT applies only to locally advanced patients undergoing neoadjuvant therapy.).
  • Exclusion Criteria:
  • 1. Pregnant or breastfeeding women, or women planning pregnancy during the trial period;
  • 2. Known hypersensitivity to FAPI, FDG, or their components, or history of severe allergic reactions;
  • 3. People with poor general condition, their heart, lung, liver, kidney and other important organ functions cannot tolerate surgery;
  • 4. Before the injection of 18F-FDG, the fasting blood glucose level exceeded 11.0 mmol/L;
  • 5. Claustrophobia or inability to tolerate PET/CT imaging (Those who cannot tolerate lying supine for 15\~30 minutes.);
  • 6. Participation in another interventional clinical trial within 30 days prior to enrollment, or planned participation during this study.

About Zhongnan Hospital

Zhongnan Hospital, affiliated with Wuhan University, is a leading medical institution in China renowned for its commitment to advancing healthcare through innovative research and clinical trials. With a focus on multidisciplinary collaboration, the hospital employs state-of-the-art facilities and a team of highly skilled professionals to conduct rigorous clinical studies aimed at improving patient outcomes. Zhongnan Hospital prioritizes ethical standards and patient safety, ensuring adherence to regulatory requirements while fostering a culture of scientific excellence. As a prominent sponsor of clinical trials, the hospital plays a pivotal role in contributing to the global medical community and enhancing the understanding of various health conditions.

Locations

Wuhan, Hubei, China

Patients applied

0 patients applied

Trial Officials

He Yong, PhD

Study Chair

Zhongnan Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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