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Evaluating Somatostatin Receptor 2 Expression Using [68Ga]Ga-DOTA-TOC PET/CT Imaging in Patients with Epstein-Barr Virus Associated Nasopharyngeal Carcinoma

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What is this study about?

This study focuses on nasopharyngeal carcinoma (NPC), which is a type of cancer that develops in the nasopharynx, the upper part of the throat behind the nose. The research specifically targets Epstein-Barr virus (EBV) associated NPC and uses [68Ga]Ga-DOTA-TOC PET/CT imaging to evaluate somatostatin receptor 2 (SSTR2) expression in tumors. The purpose of this study is to determine if this imaging technique can effectively assess tumor characteristics in patients with this specific type of cancer in regions where it is not commonly found.

Participants in this study will undergo PET imaging before and after receiving either induction chemotherapy (medication given to reduce tumor size before main treatment) or chemoradiotherapy (CRT, a combination of chemotherapy and radiation therapy). The imaging will help researchers visualize and measure how the tumor takes up the special tracer substance, which could provide important information about the tumor’s characteristics and potentially help guide future treatment decisions.

1 Initial PET/CT Scan

You will undergo a PET/CT scan before starting your cancer treatment. This scan uses a radioactive substance called gallium (68Ga) edotreotide (also known as 68Ga-Dotatoc) which is injected into your vein.

This special imaging test helps doctors see if your nasopharyngeal cancer (cancer in the upper part of the throat behind the nose) has receptors called somatostatin receptor 2 (SSTR2). The scan takes images of your entire body to identify where the cancer is located.

2 Cancer Treatment

You will receive standard treatment for your nasopharyngeal cancer. This may include either:

Induction chemotherapy (medications given to shrink the tumor before the main treatment), or

Chemoradiotherapy (CRT) without induction chemotherapy (a combination of radiation therapy and chemotherapy given at the same time).

3 Follow-up PET/CT Scan

After your cancer treatment, you will have a second PET/CT scan using the same radioactive substance (gallium-68 Dotatoc).

This follow-up scan helps doctors compare the results with your first scan to see how your tumor has responded to treatment and if there have been any changes in the SSTR2 receptors in your tumor.

4 Tissue Analysis

Your tumor tissue samples (collected before the study) will be analyzed in the laboratory to measure the actual levels of SSTR2 receptors.

Researchers will compare these tissue results with what was seen on your PET/CT scans to determine how accurate the scans are at detecting these receptors.

Who Can Join the Study?

  • You must have stage IB-IVA nasopharyngeal carcinoma (a type of cancer that starts in the nasopharynx, the upper part of the throat behind the nose)
  • Your cancer must be positive for Epstein-Barr virus (EBV), as determined by a specific test called EBER
  • You must be planned to receive either induction chemotherapy (initial treatment with anti-cancer drugs) or chemoradiation therapy (CRT) (combined chemotherapy and radiation treatment) without induction chemotherapy
  • You must be at least 18 years old
  • You must be willing to sign an informed consent form
  • You must be willing and able to follow all required study procedures
  • If you are a woman who can become pregnant, you must have a negative pregnancy test during the screening process
  • Tumor tissue samples from previous biopsies or surgeries must be available for testing

Who Cannot Join the Study?

  • You cannot participate if you have ever had an allergic reaction to octreotide (a medication similar to the one used in this study) or to the imaging agent used in the PET scan.
  • You cannot join if you are pregnant or breastfeeding.
  • You will be excluded if you have severe kidney problems (with a glomerular filtration rate less than 30 mL/min/1.73m²), as this affects how your body processes the imaging agent.
  • If you have a medical condition that prevents you from lying still during the PET scan (about 30-60 minutes), you cannot participate.
  • You cannot join if you have received radiation therapy or chemotherapy within 2 weeks before the study begins.
  • If you have other active cancers requiring treatment (besides non-melanoma skin cancer), you will not be eligible.
  • Patients with uncontrolled diabetes (blood sugar levels that are not well managed) cannot participate.
  • You cannot join if you are taking medications that might interfere with the study’s imaging agent.
  • If you cannot provide informed consent or comply with the study procedures, you will not be eligible.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Udrddcaavkgg Mstjibu Cmzkklu Gpbbaujby Groningen The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Recruiting
01.06.2025

Trial locations

[68Ga]Ga-DOTA-TOC is a radioactive substance used in PET/CT imaging. It binds to somatostatin receptors (specifically SSTR2) that may be found on certain cancer cells. In this study, it is used to create detailed images that can show if nasopharyngeal cancer cells have these specific receptors. This imaging agent helps doctors see the cancer more clearly and potentially determine if certain targeted treatments might be effective.

Nasopharyngeal carcinoma – A type of cancer that develops in the tissues of the nasopharynx, which is the upper part of the throat behind the nose. It most commonly starts in the squamous cells that line the nasopharynx. The disease often begins in the roof of the nasopharyngeal space and can spread to nearby lymph nodes in the neck. Nasopharyngeal carcinoma is frequently associated with Epstein-Barr virus (EBV) infection, particularly in endemic regions of Southeast Asia and Southern China. The cancer typically progresses by local invasion of surrounding structures and can metastasize to distant organs. Early stages may be asymptomatic or present with nasal symptoms such as blockage or bleeding.

Trial ID:
2025-520689-23-00
Protocol code:
21477
NCT ID:
NCT06982300
Trial Phase:
Human Pharmacology (Phase I) – Other

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