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: the NACASOR trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universitair Medisch Centrum Groningen

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

22 Sep 2025 → ongoing

Decision date (initial)

2025-07-14

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

External identifiers

EU CT number

2025-520689-23-00

ClinicalTrials.gov

NCT06982300

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

To 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 objectives 3

1. To 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. To evaluate normal tissue and organ distribution of [68Ga]Ga-DOTA-TOC in NPC patients.
3. To compare baseline tumor [68Ga]Ga-DOTA-TOC uptake with SSTR2 expression determined by IHC.

Conditions and MedDRA coding

nasopharyngeal carcinoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

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

Exclusion criteria 6

1. Previous treatment with chemotherapy or radiotherapy for NPC.
2. Treatment with any investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to [68Ga]Ga-DOTA-TOC injection.
3. 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.
4. Altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
5. Inability to lie in supine position for 25 minutes.
6. Patients who are pregnant or breastfeeding.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. [68Ga]Ga-DOTA-TOC PET imaging is considered feasible in patients with EBV related NPC if we can visualize and quantify tumor [68Ga]Ga-DOTA-TOC uptake in at least seven out of ten patients and complete repeat imaging in at least six patients.

Secondary endpoints 3

1. SUVpeak values of primary tumors and lymph node metastases on the pre-treatment scan.
2. SUVmean values in normal tissues and organs. Healthy lymph nodes will be defined as SUVpeak.
3. Tumor SSTR2 expression determined by IHC.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universitair Medisch Centrum Groningen

Sponsor organisation

Universitair Medisch Centrum Groningen

Address

Hanzeplein 1

City

Groningen

Postcode

9713 GZ

Country

Netherlands

Scientific contact point

Organisation

Universitair Medisch Centrum Groningen

Contact name

S.F. Oosting, MD, PhD

Public contact point

Organisation

Universitair Medisch Centrum Groningen

Contact name

S.F. Oosting, MD, PhD

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications