New scan could spot pituitary tumors more clearly
NCT ID NCT07254104
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase study tests a new radioactive tracer called [68Ga]Ga-NOTA-RF for PET scans in 30 people with pituitary tumors. The goal is to see if this tracer can better highlight tumors and help doctors tell different tumor types apart. Participants receive an injection of the tracer and then undergo a PET scan. The study focuses on imaging accuracy, not treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- [68Ga]Ga-NOTA-RF (a radioactive tracer for PET scans)
- What this could lead to
- If successful, this could lead to more accurate imaging and classification of pituitary tumors, helping doctors choose better treatments.
- What could go wrong
- This is a very early, small study (30 people) focused on imaging, not treatment. The tracer may not prove useful in practice, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age between 18 and 80 years, male or female. 2. 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. 3. 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. 4. Radiological and clinical evidence indicates residual or recurrent pituitary adenoma requiring treatment or follow-up management. 5. 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. Exclusion Criteria: 1. Pregnant or planning to become pregnant, or breastfeeding women. 2. Known history of severe allergic or anaphylactoid reactions to any component of the investigational tracer (riboflavin derivatives, NOTA chelator, or formulation excipients). 3. 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. 4. Concomitant severe systemic diseases such as cardiac, pulmonary, hepatic, or renal failure. 5. 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. 6. 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. 7. Severe claustrophobia unrelieved by sedation, or any other condition that would prevent completion of the PET scan. 8. Poor compliance or any factor judged by the investigator to affect the participant's safety or the quality of study data. 9. Any other condition that, in the judgment of the investigator, makes the participant unsuitable for study participation.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Peking Union Medical College Hospital
Beijing, China
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Other studies related to the condition(s) this trial covers.
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- Patient education may shorten hospital stays after pituitary surgery