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Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET in Diagnosing Patients With CEA Positive Cancer
NA trial testing radionuclide imaging in Breast Cancer in 20 participants. Participants enrolled and being followed up; not accepting new ones.
| Lead sponsor | City of Hope Medical Center |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 20 |
| Start date | 11 November 2015 |
| Primary completion | 6 March 2022 |
| Estimated completion | 11 August 2026 |
| Sites | 1 location across United States |
City of Hope Medical Center
18 and older, any sex, with Breast Cancer or Colon Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Tumor uptake measured by SUVmax of 64Cu-DOTA-hT4.66-M5A at day1 for hottest lesion from each patient. For tumors of at least 2 cm in diameter SUV (=tumor activity concentration/injected activity per unit body weight).
| Group | Value | 95% CI |
|---|---|---|
| Diagnostic (Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET) | 22.0 | ± 16.9 |
Tumor uptake measured by SUVmax of 64Cu-DOTA-hT4.66-M5A at day 2 for hottest lesion from each patient. For tumors of at least 2 cm in diameter SUV (=tumor activity concentration/injected activity per unit body weight).
| Group | Value | 95% CI |
|---|---|---|
| Diagnostic (Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET) | 30.7 | ± 24.4 |
Approximately 5 ml (1 teaspoon) of blood in a red top tube will be drawn at 1 month post study drug infusion and 3 months post study drug infusion. Response at either 1 or 3 months post study drug infusion constitutes a positive response.
| Group | Value | 95% CI |
|---|---|---|
| Diagnostic (Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET) | 1 |
Scan results were compared to known sites of disease as defined by sites identified on CT scans, MRI scans, FDG PET scans, or sites identified at surgery that were histologically positive for cancer. The 64Cu SUVs on both day 1 and 2 scans were evaluated in tumors and selected nontumor organs and tissues (blood pool, liver, spleen, and kidney). Tumor uptake was measured in terms of SUVmax values, while organ uptake to assess biodistribution was measured in terms of SUVmean values. Ratios of tumor-to-blood activity concentration (T:B) were calculated as the ratio of tumor SUVmax to average SUV
| Group | Value | 95% CI |
|---|---|---|
| Diagnostic (Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET) | 3.3 | ± 2.7 |
| Group | Value | 95% CI |
|---|---|---|
| Diagnostic (Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET) | 6.5 | ± 4.9 |
Time frame: Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Diagnostic (Copper Cu 64 A… |
|---|---|---|
| Hypertension | Vascular disorders | — |
| Obesity | Metabolism and nutrition disorders | — |
| Anemia | Blood and lymphatic system disorders | — |
| Sinus bradycardia | Cardiac disorders | — |
| Gastrointestinal disorders - Other, spec | Gastrointestinal disorders | — |
| General disorders and administration sit | General disorders | — |
| Platelet count decreased | Investigations | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Fatigue | General disorders | — |
| Lymphocyte count decreased | Investigations | — |
| White blood cell decreased | Investigations | — |
| Muscle weakness upper limb | Musculoskeletal and connective tissue disorders | — |
| Sinus tachycardia | Cardiac disorders | — |
| Dyspepsia | Gastrointestinal disorders | — |
| Esophageal pain | Gastrointestinal disorders | — |
| Gastric perforation | Gastrointestinal disorders | — |
| Chills | General disorders | — |
| Fever | General disorders | — |
| Catheter related infection | Infections and infestations | — |
| Alkaline phosphatase increased | Investigations | — |
| Neutrophil count decreased | Investigations | — |
| Weight loss | Investigations | — |
| Hypoalbuminemia | Metabolism and nutrition disorders | — |
| Chest wall pain | Musculoskeletal and connective tissue disorders | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — |
| Headache | Nervous system disorders | — |
| Peripheral sensory neuropathy | Nervous system disorders | — |
| Anxiety | Psychiatric disorders | — |
| Libido decreased | Psychiatric disorders | — |
| Genital edema | Reproductive system and breast disorders | — |
| Hirsutism | Skin and subcutaneous tissue disorders | — |
| Pain of skin | Skin and subcutaneous tissue disorders | — |
| Pruritus | Skin and subcutaneous tissue disorders | — |
| Skin and subcutaneous tissue disorders - | Skin and subcutaneous tissue disorders | — |
| Hypotension | Vascular disorders | — |
Data from ClinicalTrials.gov NCT02293954 adverse events section.
This pilot clinical trial studies copper Cu 64 anti-carcinoembryonic antigen (CEA) monoclonal antibody M5A positron emission tomography (PET) in diagnosing patients with CEA positive cancer. Diagnostic procedures, such as copper Cu 64 anti-CEA monoclonal antibody M5A PET, may help find and diagnose CEA positive cancer that may not be detected by standard diagnostic methods.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing