Cancer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUG68Ga-NOTA-PEG2-RM26
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.
Sponsors
Stockholm South General Hospital
Uppsala University
Karolinska University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events within 2 weeks of injection | 2 weeks | Adverse events within 2 weeks of injection and scanning of participants |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biodistribution of 68Ga-NOTA-PEG2-RM26 | During procedure | 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 |
| Dosimetry of 68Ga-NOTA-PEG2-RM26 | During procedure | 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. |
Countries
Sweden
Contacts
Primary ContactAntonios Tzortzakakis, MD, PhD
Backup ContactAnnette Fransson-Andreo-Hernandez, PhD
Outcome results
None listed