Clinical trial NCT06147362: 68Ga-NOTA-PEG2-RM26 PET/CT, First in Man Study
Official title: 68Ga-NOTA-PEG2-RM26 PET/CT: Tracer Biodistribution and Uptake in Different Kinds of Cancer With Gastrin-Releasing Peptide Receptor (GRPR) Overexpression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Cancer
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Stockholm South General Hospital
name: Uppsala University
First posted: 2023-11-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Adverse events within 2 weeks of injection
timeFrame: 2 weeks
Secondary outcomes:
measure: Biodistribution of 68Ga-NOTA-PEG2-RM26
timeFrame: During procedure
measure: Dosimetry of 68Ga-NOTA-PEG2-RM26
timeFrame: During procedure
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Karolinska University Hospital
name: Jeffrey Yachnin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: