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NCT Number: NCT06982300

SSTR2 Imaging With [68Ga]Ga-DOTA-TOC PET/CT in NPC

This is an investigator-initiated, single-center clinical trial designed to evaluate the feasibility of [68Ga]Ga-DOTA-TOC positron emission tomography (PET) scan in patients with Epstein-Barr virus (EBV) related nasopharyngeal carcinome (NPC) prior to and three weeks after the start of induction chemotherapy or concurrent chemoradiotherapy (CRT). Archival tumor tissue from the diagnostic biopsy will be used to perform somatostatin receptor 2 (SSTR2) immunohistochemistry (IHC). Blood samples will be drawn at baseline, after three weeks, after completion of induction chemotherapy if applicable, and after CRT.

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Key information

Conditions

Nasopharyngeal Carcinoma (NPC) Carcinoma Head and Neck Neoplasms Nasopharyngeal Carcinoma Nasopharyngeal Diseases Nasopharyngeal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Stage IB-IVA NPC (AJCC 9th edition), EBV positive determined by Epstein-Barr virus-encoded RNA (EBER).
  • Planned treatment with induction chemotherapy or CRT without induction chemotherapy.
  • Age ≥ 18 years.
  • Signed informed consent.
  • Willingness and ability to comply with all protocol required procedures.
  • Negative serum pregnancy test at screening in women of childbearing potential.
  • Archival tumor tissue available or consent to undergo a tumor biopsy procedure.

Exclusion criteria

  • Previous treatment with chemotherapy or radiotherapy for NPC.
  • Treatment with any investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to [68Ga]Ga-DOTA-TOC injection.
  • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or that may affect the interpretation of the results or render the patient at high risk from complications.
  • Altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
  • Inability to lie in supine position for 25 minutes.
  • Patients who are pregnant or breastfeeding.

Treatment and study plan

[68Ga]Ga-DOTA-TOC PET imaging

Other

Patients will undergo [68Ga]Ga-DOTA-TOC PET imaging before and 3 weeks after start of standard of care treatment with induction chemotherapy or CRT, unless the baseline scan shows no tracer uptake in the tumor, in that case the scan will not be repeated.

Patients will receive 120 MBq [68Ga]Ga-DOTA-TOC intravenously and will be scanned up to 20 minutes, 60 minutes after tracer injection, after acquisition of a low dose CT for attenuation correction.

The investigators will use archival tissue of the diagnostic biopsy for SSTR2 staining. If there is not sufficient tumor tissue available, a new biopsy will be performed after the baseline PET scan.

Blood samples will be drawn before the start, during and after finishing therapy at 3 or 4 different time points, depending on the treatment schedule.

Primary outcomes

  1. Feasibility of assessing tumor SSTR2 expression

    Time frame: From the day of the first study scan within one week before the start of treatment to the day of the second study scan three weeks after the start of treatment

    Determine feasibility of assessing tumor SSTR2 expression in patients with EBV-associated NPC in a non-endemic region by repeat [68Ga]Ga-DOTA-TOC PET imaging.

Secondary outcomes

  1. [68Ga]Ga-DOTA-TOC uptake in the primary tumor and lymph node metastase

    Time frame: From the day of the first study scan within one week before the start of treatment to the day of the second study scan three weeks after the start of treatment

    Determine [68Ga]Ga-DOTA-TOC uptake in the primary tumor and lymph node metastases in patients with EBV-related NPC, at baseline and early after the start of curative intent treatment, consisting of CRT with or without induction chemotherapy.

  2. [68Ga]Ga-DOTA-TOC distribution

    Time frame: From the day of the first study scan within one week before the start of treatment to the day of the second study scan three weeks after the start of treatment

    Normal tissue and organ distribution of [68Ga]Ga-DOTA-TOC in NPC patients defined by standard uptake value (SUV)

  3. Comparison [68Ga]Ga-DOTA-TOC uptake with SSTR expression

    Time frame: The day of the first study scan within one week before the start of treatment

    Comparison of tumor [68Ga]Ga-DOTA-TOC uptake on the baseline study PET scan with SSTR2 expression on the tumor biopsy, determined by IHC.

Study contacts

Contact information is provided by the study sponsor or research team.

Fleur van Doorn, MD

CONTACT

[email protected]

+31 50 361 2821

Sjoukje F. Oosting, MD, PhD

CONTACT

[email protected]

+31 50 3612821

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

Towards Improved Therapy Selection and Targeted Treatment for Nasopharyngeal Carcinoma: a Proof-of-concept Pilot Study for Somatostatin Receptor 2 Imaging With [68Ga]Ga-DOTA-TOC PET/CT.

Acronym: NACASOR

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 21, 2025
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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