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New tracer could sharpen lung cancer PET scans

NCT ID NCT07487883

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study is testing a new radioactive tracer called 68Ga-TOI-1 for PET scans in people with lung cancer or suspicious lung nodules. The tracer targets a protein (CDH3) found only on cancer cells, which may help doctors see tumors more clearly than current scans. About 80 participants will receive the tracer and undergo PET/CT imaging to see how well it detects and stages the disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
68Ga-TOI-1 (a radioactive tracer for PET scans)
What this could lead to
If successful, this could provide a more accurate way to detect and stage lung cancer, helping doctors choose the best treatment.
What could go wrong
This is an early-stage study with only 80 participants. The new tracer may not prove more effective than existing scans, and results may not apply to all lung cancer types.

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.

Participants

About 80 people

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

Started

Mar 2026

Expected to finish

Jul 2027

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.

Who is studied

This single-center, prospective, single-arm study plans to enroll 30 patients with lung cancer receiving neoadjuvant immunochemotherapy and 50 patients with pulmonary nodules highly suspected of malignancy based on clinical diagnostic criteria who are scheduled to undergo wedge resection or anatomic lobectomy/sublobar resection.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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 ≥ 18 years, male or female, with an ECOG performance status of 0 or 1; 2. Availability of complete clinical and imaging data; 3. Life expectancy ≥ 12 weeks; 4. Hematology, liver and kidney function meeting the following criteria: Hematology: WBC ≥ 4.0 × 10⁹/L or neutrophils ≥ 1.5 × 10⁹/L, PLT ≥ 100 × 10⁹/L, Hb ≥ 90 g/L; PT or APTT ≤ 1.5 × ULN; Liver and kidney function: T-Bil ≤ 1.5 × ULN, ALT/AST ≤ 2.5 × ULN, ALP ≤ 2.5 × ULN; BUN ≤ 1.5 × ULN, SCr ≤ 1.5 × ULN; 5. Patients who have not received radiotherapy or chemotherapy and are eligible for surgical resection or biopsy to obtain a pathological diagnosis, or those highly suspected of having malignant pulmonary nodules according to clinical diagnostic criteria; 6. Pathologically confirmed lung cancer via biopsy before neoadjuvant therapy; life expectancy ≥ 12 weeks; 7. Ability to provide adequate tumor tissue for testing and research. Exclusion Criteria: 1. Women who are planning pregnancy, pregnant, or breastfeeding; 2. History of other malignant tumors or prior receipt of other anti-tumor therapies; 3. Poor or missing PET scan image quality of the probe that fails to meet analysis standards; 4. Presence of claustrophobia or other mental illnesses; 5. Any other conditions deemed by the investigators as inappropriate for participation in this study.

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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

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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 University People's Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100044, China

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