Phase I Trial: 68Ga-NODAGA-E(c[RGDyK])2 Positron Emission Tomography for Imaging Angiogenesis in Primary and Metastatic Tumor Lesions in Humans

Phase 1

• Conditions: Neuroendocrine Carcinoma; Breast Cancer; Ovarian Cancer
• Interventions: Drug: Injection of 68Ga-NODAGA-E(c[RGDyK])2

• Registration Number: NCT02970786
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

The primary objective of the trial is to test the new radio tracer 68Ga-NODAGA-E\[c(RGDyK)\]2 for PET imaging of angiogenesis. The tracer has the potential of identifying tumors with a high level of angiogenesis, which is one of the cancer hallmarks. Furthermore, the tracer can potentially be used in early response assessment to anti-angiogenic treatment.

This is a first-in-man study to test the radio tracer in cancer patients. Safety, biodistribution and dosimetry will be evaluated by repeated PET imaging (10 minutes, 1 hour and 2 hours post injection).

Detailed Description

The primary objective of the trial is to test the new radio tracer 68Ga-NODAGA-E\[c(RGDyK)\]2 for PET imaging of angiogenesis. The tracer has the potential of identifying tumors with a high level of angiogenesis, which is one of the cancer hallmarks. Furthermore, the tracer can potentially be used in early response assessment to anti-angiogenic treatment.

This is a first-in-man study to test the radio tracer in cancer patients. Safety, biodistribution and dosimetry will be evaluated by repeated PET imaging (10 minutes, 1 hour and 2 hours post injection).

The primary end points are safety, biodistribution and dosimetry of 68Ga-NODAGA-E\[c(RGDyK)\]2. In addition, the quantitative uptake of 68Ga-NODAGA-E\[c(RGDyK)\]2 will be compared to the expression of integrin αvβ3 measured directly in tumor tissue obtained by surgery or biopsies. The study will be monitored and evaluated in accordance with the principles of Good Clinical Practice (GCP).

Study Timeline

• Status Verified: 2016-11
• Study Start: 2016-11
• Study First Submitted: 2016-11-15
• Study First Submitted QC: 2016-11-18
• Last Update Submitted: 2016-11-18
• Study First Posted: 2016-11-22
• Last Update Posted: 2016-11-22
• Primary Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Diagnosed with neuroendocrine cancer, breast cancer or ovarian cancer
• Capable of understanding and giving full informed consent

Exclusion Criteria

• Pregnancy
• Lactation
• Obesity (weight above 140 kg)
• Claustrophobia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
68Ga-NODAGA-E(c[RGDyK])2 PET	Injection of 68Ga-NODAGA-E(c[RGDyK])2	One injection of 68Ga-NODAGA-E(c\[RGDyK\])2 PET (app. 200 MBq) followed by 3 PET/CT scans 10 minutes, 1 hour and 2 hours post injection

Primary Outcome Measures

Name	Time	Method
Safety of 68Ga-NODAGA-E(c[RGDyK])2 PET as measured by the number of participants with adverse events and significant changes in vital signs, electrocardiogram, and laboratory data.	48 hours
Biodistribution	2 hours	Change in biodistribution estimated by PET
Dosimetry	2 hours	Dosimetry will be calculated with the use of OLINDA/EXM software (mSv) based on repeated PET imaging with the radiotracer 68Ga-NODAGA-E(c\[RGDyK\])2.

Secondary Outcome Measures

Name	Time	Method
Quantitative uptake of the radiotracer 68Ga-NODAGA-E(c[RGDyK])2 in tumor tissue	2 hours	The patients will be PET scanned 10 minutes, 1 hour and 2 hours post injection of the radiotracer 68Ga-NODAGA-E(c\[RGDyK\])2. These timepoints will be used for assessment of tumor uptake by the use of maximum and mean standardized uptake value (SUV).

Trial Locations

Locations (1)

Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet; 🇩🇰 Copenhagen, Denmark