Can a new PET tracer reveal hidden immune clues in tumors?
NCT ID NCT04605614
First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time
Summary
This phase I trial tests an experimental imaging agent called 64Cu-DOTA-pembrolizumab, which is designed to attach to PD1, a protein on immune cells that often cluster around tumors. By injecting this agent and then performing a PET scan, researchers hope to see where these immune cells are in the body, potentially detecting them even when they are too small for standard scans. The study includes people with certain blood or solid tumors who plan to receive immunotherapy. The main goals are to find the safest dose and to see if this imaging method can help predict whether a patient will respond to immunotherapy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Copper Cu 64-DOTA-pembrolizumab, a radiotracer that binds to PD1 on immune cells, given intravenously before a PET scan
- What this could lead to
- If successful, this imaging approach could help doctors see whether a patient's tumor has the right immune cells to respond to immunotherapy, guiding treatment decisions.
- What could go wrong
- This is an early-phase trial focused on safety and dosing, so the imaging agent may not prove accurate or beneficial. There are also risks from radiation exposure and potential side effects.
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
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Expected to start
-
Apr 2022
An estimate. Start dates often move.
- Finished
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May 2022
- 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
-
18 years and older
- Sex
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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 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: * All subjects must have the ability to understand and the willingness to sign a written informed consent * Ability to undergo standard PET imaging * Plan to be treated with immunotherapy * Karnofsky performance status (KPS) \>= 50% * Absolute neutrophil count (ANC) \>= 1000/mm\^3 * Platelet count \>= 50/mm\^3; platelet transfusions to help patients meet eligibility criteria are not allowed within 7 days before study enrollment * Total bilirubin =\< 1.5 x the upper limit of normal (ULN) * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3 x ULN * Calculated creatinine clearance \>= 30 mL/min * Woman of childbearing potential must be practicing a highly effective method of birth control consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies: e.g., established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device or intrauterine system; barrier methods; condom with spermicidal foam/gel/film/cream/suppository or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; male partner sterilization; true abstinence (when this is in line with the preferred and usual lifestyle of the subject) during and after the study (6 months after the last dose of 64Cu-anti-PD1 \[pembrolizumab\]-N-hydroxysuccinimide \[NHS\]-DOTA for women) * A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control, e.g., either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also not donate sperm during the study and for 6 months after receiving the last dose of study drug Exclusion Criteria: * Prior exposure to pembrolizumab or other anti-PD1 therapy * Unable to tolerate PET scan * Any condition that would, in the investigator's judgement, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures * Female patients who are lactating or have a positive pregnancy test during the screening period * Infection requiring systemic antibiotic therapy within 14 days prior to start of study treatment * Subject is receiving concurrent chemotherapy or biologic or hormonal therapy for cancer treatment. Subject is receiving bone marrow stimulatory factors (e.g., granulocyte-macrophage colony-stimulating factor \[GM-CSF\]). Note: Concurrent use of hormones for noncancer-related conditions (e.g., insulin for diabetes) is acceptable * Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study * Vaccination with live attenuated vaccines within 4 weeks of study agent administration * Subject is currently using or has used immunosuppressive medication within 14 days prior to the study agent administration * Intranasal, topical, inhaled, or local steroid injections (e.g., intra-articular injection) * Chronic systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent * Steroids as premedication for hypersensitivity reactions (e.g., infusion-related reactions, computed tomography \[CT\] scan premedication) * Subject has plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloidosis * Subject has known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) \< 50% predicted normal. Note that FEV1 testing is required for patients suspected of having COPD and subjects must be excluded if FEV1 \< 50% * Subject has known allergies, hypersensitivity, or intolerance to monoclonal antibodies or human proteins, or their excipients * Subject has history of primary immunodeficiency * Subject is positive for human immunodeficiency virus (HIV-1), chronic or active hepatitis B, or active hepatitis A or C * Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
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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.
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