Clinical trial · Interventional
68Ga-NOTA-PEG2-RM26 PET/CT, First in Man Study
68Ga-NOTA-PEG2-RM26 PET/CT: Tracer Biodistribution and Uptake in Different Kinds of Cancer With Gastrin-Releasing Peptide Receptor (GRPR) Overexpression
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-PEG2-RM26 in prostate cancer patients. A single dose of 2 MBq/kg of 68Ga-NOTA-PEG2-RM26 limited to 100-200 MBq per examination will be given intravenously. Visual and semiquantitative method will be used to assess PET/CT images.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-NOTA-PEG2-RM26 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-NOTA-PEG2-RM26
- description
- Participants will be injected with 2 MBq/kg of 68Ga-NOTA-PEG2-RM26 limited to 100-200 MBq and then undergo PET/CT examination.
- interventionNames
- Drug: 68Ga-NOTA-PEG2-RM26
Primary outcomes (1)
- measure
- Adverse events within 2 weeks of injection
- timeFrame
- 2 weeks
- description
- Adverse events within 2 weeks of injection and scanning of participants
Secondary outcomes (2)
- measure
- Biodistribution of 68Ga-NOTA-PEG2-RM26
- timeFrame
- During procedure
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Primary/recurrent or metastatic cancer in: prostate cancer, breast cancer, colorectal cancer, gastrointestinal carcinoid, gastric cancer, or lung cancer * Histopathological diagnosis * Age 18 years or more and palliative disease OR age above 50 years * Adequate bone marrow, hepatic and renal function, Eastern Cooperative Oncology Group Performance Status Scale 0 or 1 and a negative pregnancy test Exclusion Criteria: * Age less than 18 years * Less than 6 months since a clinically significant cardiovascular event such as myocardial infarction, unstable angina, angioplasty, bypass surgery, stroke or transient ischemic attack * Congestive heart failure New York Heart Association class ≥ II * Pregnant or breast-feeding women * Patients with reproductive potential not implementing accepted and effective means of contraception * Participation in any other clinical trial within the previous 4 weeks * Unable to comply with study procedures (e.g., claustrophobia, low back pain not allowing the patient to lay down in the examination bed)
References
Publications (1)
- DERIVEDBjareback A, Estenberg U, Tzortzakakis A, Axelsson R, Li C, Altena R, Tran TA, Hindorf C. First-in-human radiation dosimetry of the GRPR antagonist [68Ga]Ga-NOTA-PEG2-RM26 in patients with prostate and breast cancer. EJNMMI Res. 2026 Jun 18;16(1):96. doi: 10.1186/s13550-026-01472-2. PMID 42310173