Clinical Evaluation of [68Ga]Ga-NOTA-RF PET Imaging Targeting RFVT3 in Patients With Pituitary Tumors

NCT07254104 | Enrolling By Invitation Early Phase 1

• 1 other identifier: PUMCH-RFVT3
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pituitary Neoplasms

Outcome Measures

Primary Outcomes (1)

• SUVmax

  The tumor uptake capacity (expressed as SUV values) of \[68Ga\]Ga-NOTA-RF PET imaging in intracranial tumors.

  After the completion of the PET examination.

Study Arms (1)

Pituitary Neoplasms

EXPERIMENTAL

Participants with pituitary neoplasms will undergo \[68Ga\]Ga-NOTA-RF PET/CT imaging to evaluate tracer uptake, biodistribution, and safety.

Drug: [68Ga]Ga-NOTA-RF

Interventions

[68Ga]Ga-NOTA-RF DRUG

Administer the \[68Ga\]Ga-NOTA-RF radiotracer via injection.

Also known as: [68Ga]Ga-RF PET tracer

Pituitary Neoplasms

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

Location

MeSH Terms

Conditions

Pituitary Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases

Study Officials

• Xianzhong Zhang

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 28, 2025
• Study Start: November 17, 2025
• Primary Completion (Estimated): October 13, 2026
• Study Completion (Estimated): October 13, 2026
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)