68Ga-NOTA-PEG2-RM26 PET/CT, First in Man Study

NCT06147362 | Unknown Phase 1 DMC

• 1 other identifier: EudraCT 2021-004980-28
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• Adverse events within 2 weeks of injection

  Adverse events within 2 weeks of injection and scanning of participants

  2 weeks

Secondary Outcomes (2)

• Biodistribution of 68Ga-NOTA-PEG2-RM26

  During procedure

• Dosimetry of 68Ga-NOTA-PEG2-RM26

  During procedure

Study Arms (1)

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.

Drug: 68Ga-NOTA-PEG2-RM26

Interventions

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.

68Ga-NOTA-PEG2-RM26

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Karolinska University Hospital: lead
• Stockholm South General Hospital: collaborator
• Uppsala University: collaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, 17176, Sweden

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Jeffrey Yachnin, MD, PhD

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Section Head Early Clinical Trial Unit

Model Details: 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.

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: November 27, 2023
• Study Start: June 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: November 27, 2023

Record last verified: 2023-11

Locations

SE (1)