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Single Microdose Trial- CXCR4 PET Tracer - Pharmacokinetics and Pharmacodynamics of [68Ga]Ga-R54, a Radiopharmaceutical Directed Toward CXCR4 in Patients With Advanced Solid Neoplasia.

ConditionsAdvanced Solid TumorMultiple Myeloma
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Cancer Institute, Naples

About this trial

Phase 1, monocentric, open labeled, no profit "Microdose" trial. A single microdose of the new \[68Ga\]Ga-R54 PET radiopharmaceutical directed against CXCR4 will be injected into patients with advanced solid tumor or multiple myeloma to evaluate the binding.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients > 18 years

Patients with histological diagnosis of solid neoplasm (breast, lung, colon, ovary, pancreas) in advanced stages or multiple myeloma evaluated by PET/CT with [18F]FDG carried out in the 3 months prior to enrollment. The neoplasm must express the CXCR4 receptor by immunohistochemistry

Patients with ECOG performance status 0-2, able to undergo the scheduled diagnostic procedure (PET/CT with [68Ga]Ga-R54).

Patients with alkaline phosphatase (AP), alanine aminotransferase (ALT), and aspartate aminotransferase <3 x upper limit of reference range and total bilirubin <2.0 mg/dL

Disqualifiers

Presence of active infections (e.g. requiring antibiotic therapy) or other serious concomitant illness, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study

Declared chronic active hepatitis (hepatitis B / C)

Declared active autoimmune diseases

Recovery from major trauma including surgery within 4 weeks of study enrollment

Trial design

Design model

Single group

Treatments tested in this trial

  • [68Ga]Ga-R54 PET/CT

    Drug

    A single intravenous microdose (≤100 μg) of the CXCR4-targeting radiopharmaceutical \[68Ga\]Ga-R54 is administered, followed by whole-body PET/CT imaging. Serial blood samples are collected up to 4 hours post-injection to assess pharmacokinetics. Imaging is performed according to institutional standards to evaluate in vivo CXCR4 expression in tumor lesions.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: [68Ga]Ga-R54 PET/CT scanExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Quantitative analysis of the uptake (pharmacodynamics) of [68Ga]Ga-R54 in the neoplastic lesion by measuring the "maximum standardized uptake value" (SUVmax).

Time frame
Single time point at PET/CT imaging (Day 1)
2

Pharmacokinetics of the PET radiopharmaceutical [68Ga]Ga-R54 through measurement of radioactivity in blood at the gamma counter (%ID/g).

Time frame
Peri-procedural (at time of PET/CT imaging, Day 1)

Secondary outcomes

1

Evaluation of the dosimetric parameters for the tumor and for healthy organs by determining the absorbed dose per unit of activity administered (mGy/MBq).

Time frame
From time of [68Ga]Ga-R54 administration up to 4 hours post-injection
2

SUVmax correlation of the radiopharmaceutical [68Ga]Ga-R54 and CXCR4 expression assessed by immunohistochemistry in the tumor and microenvironment.

Time frame
Single time point at PET/CT imaging (Day 1)

Other outcomes

Sponsors and contacts

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National Cancer Institute, Naples

Lead sponsor

Source ClinicalTrials.gov
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