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New scan could spot pituitary tumors more clearly

NCT ID NCT07254104

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

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

18 to 80 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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.

    Open the record ↗

  3. 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

  • Peking Union Medical College Hospital

    Beijing, China

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