New PET scan trick may spot fake tumor growth in immunotherapy patients
NCT ID NCT03584334
First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 1 time
Summary
This study looked at whether a special PET scan (18FDG dual-point) can tell the difference between real tumor growth and harmless inflammation caused by immunotherapy. Researchers studied 100 people with advanced lung cancer or melanoma who were being treated with drugs like nivolumab or pembrolizumab. The goal was to find a better way to evaluate treatment response without confusing inflammation for cancer progression.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 18FDG PET scan (diagnostic imaging)
- What this could lead to
- If successful, this could help doctors quickly tell whether a tumor is truly growing or just inflamed from treatment, avoiding unnecessary changes in therapy.
- What could go wrong
- This is an observational study, not a treatment trial. The results may not apply to all patients or cancer types, and the scan technique is not yet standard practice.
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
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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100 people
The number who actually took part.
- Started
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Apr 2019
- Finished
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Jun 2024
- 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 years and older
- Sex
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Anyone
- Healthy volunteers
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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 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: * Age \> or = 18 years, * Patients with unresectable melanoma or histologically proven, metastatic or locally advanced NSCLC, * Indication of an immunotherapy treatment with nivolumab or pembrolizumab validated in multidisciplinary consultation team and prescribed as part of their marketing authorization, in first or second line of treatment, * Performance Status 0 to 2, * Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required, * Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 6 months after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year, * Male subjects should agree to use an adequate method of contraception or abstain from heterosexual activity starting with the first dose of study therapy through 6 months after the last dose of study therapy, * Patient willing and able to provide written informed consent/assent for the trial, * Patient affiliated with a health insurance system. Exclusion Criteria: * Age \< 18 years, * Contraindication to performing 18FDG PET scans: severe claustrophobia, unbalanced diabetes during PET examinations (fasting capillary blood glucose ≥ 11 mmol), * Any participation in other biomedical studies related to the drug, medical devices or imaging techniques is prohibited except biomedical studies called overstudies (In case of doubt or questions about the patient's participation in a other clinical study, please contact the sponsor), * Contraindication to nivolumab or pembrolizumab treatment, * Patient with metastatic disease, * History of thoracic irradiation or near / in the thoracic irradiation field, * Patient who refuses to participate in the study or unable to agree, * Patient currently receiving one or more treatments described in section 6.9 of the protocol, * Contraindication to nivolumab or pembrolizumab treatment, * People particularly vulnerable as defined in Articles L.1121-5 to -8 of the French Healthcare Code, including: person deprived of freedom by an administrative or judicial decision, adult being the object of a legal protection measure or outside a state to express their consent, pregnant or breastfeeding women.
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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.
Contacts and locations
Locations
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Centre Antoine Lacassagne
Nice, 06189, France
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