Health Condition 1: C50- Malignant neoplasm of breast Health Condition 2: C34- Malignant neoplasm of bronchus andlung Health Condition 3: C64- Malignant neoplasm of kidney, except renal pelvis
Conditions
Interventions
Intervention1: 68 Ga Scan: One-time PETCT Scan using Kisspeptin Receptor based Gallium68
Control Intervention1: FDG PET Scan: One-Time PETCT Using conventional Fluorodeoxyglucose (FDG) PET
Sponsors
Radionetics Oncology Inc.
Eligibility
Inclusion criteria
Inclusion criteria: - Cohort Specific Criteria -- Cohort 1: Locoregionally recurrent or metastatic breast carcinoma with progressive disease. -- Cohort 2: Metastatic clear cell renal cell carcinoma with progressive disease. -- Cohort 3: Locally advanced or metastatic non-small cell lung cancer with progressive disease. Common Criteria - Availability of standard-of-care images within 28 days of dosing with 68Ga-R10306 (obtained in the same study center where the 68Ga-R10306 PET/CT is performed). - At least one measurable target lesion per RECIST 1.1 criteria within 28 days of dosing with 68Ga-R10306. - Male or non-pregnant, non-lactating females. - Female Study Participants of child-bearing potential and male Study Participants (if sexually active) must agree to use adequate method(s) of effective contraception during their participation in the study. -- Medically acceptable adequate contraception for sexually active females with child-bearing potential include: 1) surgical sterilization (such as tubal ligation or hysterectomy), 2) approved hormonal contraceptives, 3) barrier method (such as condom or diaphragm) used with a spermicide, or 4) intrauterine device (IUD). -- Medically acceptable adequate contraception for sexually active males include: 1) surgical sterilization (such as vasectomy), 2) a condom used with a spermicide. - Eastern Cooperative Oncology Group (ECOG) Performance Status =2. - Adequate hepatic function as defined below (within 28 days of dosing with 68Ga-R10306): a. Serum alanine aminotransaminase (ALT)/ aspartate aminotransaminase (AST) =3 × upper limit of normal (ULN) or =5 × ULN if liver metastases are present or received prior mitotane therapy, and b. Serum bilirubin – total =1.5 × ULN (unless due to Gilbert’s syndrome or hemolysis in which case total =3.0 × ULN). - Adequate renal function as measured by creatinine clearance calculated by the Cockcroft-Gault formula (=60 mL/minute), determined within 28 days of dosing with 68Ga-R10306. - Able to understand and willing to sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1.Administered a radionuclide within a period corresponding to less than 10 physical half-lives of the radionuclide prior to dosing with 68Ga-R10306. 2.Radiotherapy =14 days prior to dosing with 68Ga-R10306. 3.Major surgery =21 days prior to dosing with 68Ga-R10306 or has not recovered from adverse effects of such procedure. 4.Severe or unstable medical condition, such as congestive heart failure (New York Heart Association [NYHA] Class III or IV), ischemic heart disease, uncontrolled hypertension, uncontrolled diabetes mellitus, as well as an uncontrolled cardiac arrhythmia requiring medication (=Grade 2, according to NCI-CTCAE Version 5.0), myocardial infarction within 6 months prior to starting Investigational Product, or any other significant or unstable concurrent cardiac illness. Note: Stable chronic atrial fibrillation is allowed. 5.History of cerebrovascular accident within 6 months or that resulted in ongoing neurologic instability. 6.Major active infection requiring antibiotics. 7.Known active human immunodeficiency virus infection or active infection with Hepatitis B or C. 8.Acute illness within 14 days prior to dosing with 68Ga-R10306 unless mild in severity, as assessed by the Investigator. 9.Any other condition that in the opinion of the Investigator would place the Study Participant at an unacceptable risk or cause the Study Participant to be unlikely to fully participate or comply with study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Assessments and Adverse Event ReportingTimepoint: Until 24 hours from the scan | — |
Secondary
| Measure | Time frame |
|---|---|
| NilTimepoint: NA | — |
Countries
India
Contacts
Public ContactDr Kumar G Kallur
HealthCare Global Enterprises Ltd.
Outcome results
None listed