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| Name | Class |
|---|---|
| Stockholm South General Hospital | OTHER |
| Uppsala University | OTHER |
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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.
The gastrin-releasing peptide receptor (GRPR), also known as bombesin receptor subtype II (BB2), is a member of the G protein-coupled receptor family of bombesin receptors. GRPR is over-expressed in various types of human tumors. RM26, a GRPR antagonist with high affinity, was discovered by peptide backbone modification of bombesin analogues.
To target gastrin-releasing peptide receptor in human neoplastic cells NOTA-PEG2-RM26 was synthesised and then labeled with 68Ga.
An open-label whole-body PET/ CT study was designed to investigate the safety and dosimetry of 68Ga-NOTA-PEG2-RM26 and to assess its clinical diagnostic value in patients with cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 68Ga-NOTA-PEG2-RM26 | Experimental | Participants will be injected with 2 MBq/kg of 68Ga-NOTA-PEG2-RM26 limited to 100-200 MBq and then undergo PET/CT examination. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-NOTA-PEG2-RM26 | Drug | Single-dose 68Ga-NOTA-PEG2-RM26, a gastrin-releasing peptide receptor antagonist linked with a positron emitting radioisotope intravenously injected into participants before the PET/CT scans. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events within 2 weeks of injection | Adverse events within 2 weeks of injection and scanning of participants | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Biodistribution of 68Ga-NOTA-PEG2-RM26 | The semiquantitative analysis will be performed by the same person for all the cases, uptake in organs with uptake above the blood pool will bes described | During procedure |
| Dosimetry of 68Ga-NOTA-PEG2-RM26 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonios Tzortzakakis, MD, PhD | Contact | 08-123 70 000 | antonios.tzortzakakis@regionstockholm.se | |
| Annette Fransson-Andreo-Hernandez, PhD | Contact | +468 517 753 74 | annette.fransson-andreo-hernandez@regionstockholm.se |
| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Yachnin, MD, PhD | Karolinska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital | Recruiting | Stockholm | 17176 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42310173 | Derived | Bjareback 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. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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Approximately ten patients (with primary/recurrent or metastatic cancer) in each of the following six cancer groups, prostate cancer, breast cancer, colorectal cancer, gastrointestinal carcinoid, gastric cancer, and lung cancer, will be recruited and examined.
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Mean absorbed radiation doses will be estimated using the source and target organ framework outlined by the Medical Internal Radiation Dose Committee. Absorbed and effective radiation doses will be calculated.
| During procedure |