Pituitary NeoplasmsEarly Phase 1NCT07254104
Clinical Evaluation of [68Ga]Ga-NOTA-RF PET Imaging Targeting RFVT3 in Patients With Pituitary Tumors
A Early Phase 1 study testing [68Ga]Ga-NOTA-RF in people with Pituitary Neoplasms, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This study aims to evaluate the clinical application value of [68Ga]Ga-NOTA-RF, a novel PET molecular probe targeting riboflavin transporter 3 (RFVT3), in patients with pituitary adenomas. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pituitary Neoplasms
- What is being tested?
- [68Ga]Ga-NOTA-RF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 17 Nov 2025to 13 Oct 2026
- Phase
- Early Phase 1
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18 and 80 years, male or female.
- Able to understand and sign written informed consent, willing to follow pre-injection preparation requirements (adequate hydration and avoidance of high-dose riboflavin supplements), and to complete all study procedures.
- Recurrent invasive pituitary adenoma within 6 months after surgery, without intracranial or distant metastasis. The postoperative pathological Ki-67 index of the previous pituitary tumor is ≥3%, and tumor growth cannot be controlled by standard medical therapy and radiotherapy.
- Radiological and clinical evidence indicates residual or recurrent pituitary adenoma requiring treatment or follow-up management.
- At least one measurable and resectable lesion suitable for correlation with PET imaging evaluation; vital signs are stable, and the participant is able to lie supine and cooperate during a 30-60 minute PET scan.
Who cannot join
- Pregnant or planning to become pregnant, or breastfeeding women.
- Known history of severe allergic or anaphylactoid reactions to any component of the investigational tracer (riboflavin derivatives, NOTA chelator, or formulation excipients).
- Presence of severe or uncontrolled medical conditions (e.g., decompensated heart failure, active infection, myocardial infarction or stroke within the past 4 weeks) that, in the opinion of the investigator, make the participant unsuitable for PET imaging.
- Concomitant severe systemic diseases such as cardiac, pulmonary, hepatic, or renal failure.
- Pituitary adenoma patients who underwent surgery less than 4 weeks prior to enrollment or completed radiotherapy to the sellar region within the past 3 months.
- Participation in another interventional clinical trial within the past 4 weeks, or cumulative radiation exposure from prior research procedures within the past 12 months that may exceed the ethical safety limit.
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- Severe claustrophobia unrelieved by sedation, or any other condition that would prevent completion of the PET scan.
- Poor compliance or any factor judged by the investigator to affect the participant's safety or the quality of study data.
- Any other condition that, in the judgment of the investigator, makes the participant unsuitable for study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This study aims to evaluate the clinical application value of [68Ga]Ga-NOTA-RF, a novel PET molecular probe targeting riboflavin transporter 3 (RFVT3), in patients with pituitary adenomas. It will observe the probe's imaging characteristics, distribution signs, and the relationships between these factors, tumor differentiation degree, and radiotracer uptake. Additionally, the study will explore the diagnostic advantages of [68Ga]Ga-NOTA-RF in patients with pituitary adenomas and its potential value in precise typing.
Read the detailed description
This study aims to evaluate the potential clinical application of [68Ga]Ga-NOTA-RF in pituitary adenomas. Such tumors are characterized by variable degrees of differentiation, subtle early morphological changes, complex metabolic states, and a strong dependence on mitochondrial activity. Existing imaging modalities have limited performance in detecting and characterizing these lesions, highlighting the need for novel metabolic imaging tools. This study will systematically investigate the biodistribution and imaging characteristics of [68Ga]Ga-NOTA-RF in pituitary adenomas, as well as its correlation with RFVT3 expression, to explore its potential value in early tumor detection, metabolic subtype differentiation, and molecular classification.
- Conditions
- Pituitary Neoplasms
- Being tested
- [68Ga]Ga-NOTA-RF
- Medical subject headings
- Pituitary Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]Ga-NOTA-RFDrug
Also called [68Ga]Ga-RF PET tracer
Administer the [68Ga]Ga-NOTA-RF radiotracer via injection.
| Study group | Role | What they receive |
|---|---|---|
| Pituitary Neoplasms | Experimental | Participants with pituitary neoplasms will undergo [68Ga]Ga-NOTA-RF PET/CT imaging to evaluate tracer uptake, biodistribution, and safety. Receives: Drug: [68Ga]Ga-NOTA-RF |
What is being measured
The primary outcome is the main question the study is designed to answer.
SUVmax
The tumor uptake capacity (expressed as SUV values) of [68Ga]Ga-NOTA-RF PET imaging in intracranial tumors.
Measured: After the completion of the PET examination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start17 Nov 2025
- Primary completion13 Oct 2026 (estimated)
- Study completion13 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pituitary NeoplasmsStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xianzhong Zhang, Peking Union Medical College Hospital
- Investigators
- Xianzhong Zhang, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07254104
- Sponsor's protocol ID
- PUMCH-RFVT3
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of [68Ga]Ga-NOTA-RF PET Imaging Targeting RFVT3 in Patients With Pituitary Tumors
- ClinicalTrials.gov ID
- NCT07254104
- Acronym / sponsor ID
- PUMCH-RFVT3
- Conditions
- Pituitary Neoplasms
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- 13 Oct 2026 (estimated)
- Study completion
- 13 Oct 2026 (estimated)
- First posted
- 28 Nov 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 study aims to evaluate the clinical application value of [68Ga]Ga-NOTA-RF, a novel PET molecular probe targeting riboflavin transporter 3 (RFVT3), in patients with pituitary adenomas. It will observe the probe's imaging characteristics, distribution signs, and the relationships between these factors, tumor differentiation degree, and radiotracer uptake. Additionally, the study will explore the diagnostic advantages of [68Ga]Ga-NOTA-RF in patients with pituitary adenomas and its potential value in precise typing.
Detailed description
This study aims to evaluate the potential clinical application of [68Ga]Ga-NOTA-RF in pituitary adenomas. Such tumors are characterized by variable degrees of differentiation, subtle early morphological changes, complex metabolic states, and a strong dependence on mitochondrial activity. Existing imaging modalities have limited performance in detecting and characterizing these lesions, highlighting the need for novel metabolic imaging tools. This study will systematically investigate the biodistribution and imaging characteristics of [68Ga]Ga-NOTA-RF in pituitary adenomas, as well as its correlation with RFVT3 expression, to explore its potential value in early tumor detection, metabolic subtype differentiation, and molecular classification.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pituitary Neoplasms | Experimental | Drug: [68Ga]Ga-NOTA-RFParticipants with pituitary neoplasms will undergo [68Ga]Ga-NOTA-RF PET/CT imaging to evaluate tracer uptake, biodistribution, and safety. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 80 years, male or female.
- Able to understand and sign written informed consent, willing to follow pre-injection preparation requirements (adequate hydration and avoidance of high-dose riboflavin supplements), and to complete all study procedures.
- Recurrent invasive pituitary adenoma within 6 months after surgery, without intracranial or distant metastasis. The postoperative pathological Ki-67 index of the previous pituitary tumor is ≥3%, and tumor growth cannot be controlled by standard medical therapy and radiotherapy.
- Radiological and clinical evidence indicates residual or recurrent pituitary adenoma requiring treatment or follow-up management.
- At least one measurable and resectable lesion suitable for correlation with PET imaging evaluation; vital signs are stable, and the participant is able to lie supine and cooperate during a 30-60 minute PET scan.
Key exclusion criteria (9 listed)
- Pregnant or planning to become pregnant, or breastfeeding women.
- Known history of severe allergic or anaphylactoid reactions to any component of the investigational tracer (riboflavin derivatives, NOTA chelator, or formulation excipients).
- Presence of severe or uncontrolled medical conditions (e.g., decompensated heart failure, active infection, myocardial infarction or stroke within the past 4 weeks) that, in the opinion of the investigator, make the participant unsuitable for PET imaging.
- Concomitant severe systemic diseases such as cardiac, pulmonary, hepatic, or renal failure.
- Pituitary adenoma patients who underwent surgery less than 4 weeks prior to enrollment or completed radiotherapy to the sellar region within the past 3 months.
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-NOTA-RFAlso: [68Ga]Ga-RF PET tracerAdminister the [68Ga]Ga-NOTA-RF radiotracer via injection. | Drug | Pituitary Neoplasms |
Primary outcome
SUVmax
Time frame: After the completion of the PET examination.
The tumor uptake capacity (expressed as SUV values) of [68Ga]Ga-NOTA-RF PET imaging in intracranial tumors.
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 28 Nov 2025.
- Individual participant dataSharing planned: No
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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.
Xianzhong Zhang principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing [68Ga]Ga-NOTA-RF in people with Pituitary Neoplasms, run by Peking Union Medical College Hospital at 1 site in China.
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 5 inclusion and 9 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: enrolling by invitation, as of the sponsor's last update on 28 Nov 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 China. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SUVmax (time frame: After the completion of the PET examination.). 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 28 Nov 2025; AzTrials last refreshed its copy on 7 Nov 2026.