Nasopharyngeal Carcinoma (NPC)Phase 1/2NACASORNCT06982300
SSTR2 Imaging With [68Ga]Ga-DOTA-TOC PET/CT in NPC
A Phase 1/2 study testing [68Ga]Ga-DOTA-TOC PET imaging in people with Nasopharyngeal Carcinoma (NPC), run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasopharyngeal Carcinoma (NPC)
- What is being tested?
- [68Ga]Ga-DOTA-TOC PET imaging
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- 25 Sep 2025to Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Groningen
Groningen, 9713 GZ
Sjoukje F. Oosting, MD, PhD, +31 50 361 2821, s.oosting@umcg.nl
Fleur van Doorn, MD, +31 50 361 2821, f.l.van.doorn@umcg.nl
About this study
Official 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.
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.
- Conditions
- Nasopharyngeal Carcinoma (NPC)
- Being tested
- [68Ga]Ga-DOTA-TOC PET imaging
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]Ga-DOTA-TOC PET imagingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| [68Ga]Ga-DOTA-TOC PET imaging | Experimental | Not described Receives: Other: [68Ga]Ga-DOTA-TOC PET imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of assessing tumor SSTR2 expression
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.
Measured: 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
Secondary outcomes (3)
[68Ga]Ga-DOTA-TOC uptake in the primary tumor and lymph node metastase
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.
Measured: 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
[68Ga]Ga-DOTA-TOC distribution
Normal tissue and organ distribution of [68Ga]Ga-DOTA-TOC in NPC patients defined by standard uptake value (SUV)
Measured: 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
Comparison [68Ga]Ga-DOTA-TOC uptake with SSTR expression
Comparison of tumor [68Ga]Ga-DOTA-TOC uptake on the baseline study PET scan with SSTR2 expression on the tumor biopsy, determined by IHC.
Measured: The day of the first study scan within one week before the start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start25 Sep 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal Carcinoma (NPC)Studies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sjoukje F. Oosting, MD, PhD, Principal investigator, University Medical Center Groningen, Dept. of Medical Oncology, Hanzeplein 1, 9713 GZ Groningen, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06982300
- Sponsor's protocol ID
- 21477
- Other IDs
- 2025-520689-23-00, 2025
- Acronym
- NACASOR
- Status last verified
- Sep 2025
- First submitted
- 25 Apr 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision whether or not to share IPD will be made after consultation of the PI.
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT06982300
- Acronym / sponsor ID
- NACASOR / 21477
- Conditions
- Nasopharyngeal Carcinoma (NPC)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 25 Sep 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [68Ga]Ga-DOTA-TOC PET imaging | Experimental | Other: [68Ga]Ga-DOTA-TOC PET imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [68Ga]Ga-DOTA-TOC PET imagingPatients 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. | Other | [68Ga]Ga-DOTA-TOC PET imaging |
Primary outcome
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.
3 secondary outcomes
[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
[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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Individual participant dataSharing planned: Undecided. The decision whether or not to share IPD will be made after consultation of the PI.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sjoukje F. Oosting, MD, PhD principal investigator
University Medical Center Groningen, Dept. of Medical Oncology, Hanzeplein 1, 9713 GZ Groningen, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing [68Ga]Ga-DOTA-TOC PET imaging in people with Nasopharyngeal Carcinoma (NPC), run by University Medical Center Groningen at 1 site in Netherlands.
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 7 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 3 Oct 2025. 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 Netherlands. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sjoukje F. Oosting, MD, PhD (+31 50 3612821, s.oosting@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 3 Oct 2025.