CD70-targeted immunoPET Imaging of Malignant Cancers

NCT06852638 | Recruiting

• 1 other identifier: LY2024-306-A
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to establish and optimize the cluster of differentiation (CD70)-targeted immuno-positron emission tomography/computed tomography (immunoPET/CT) imaging method and its physiological and pathological distribution characteristics, based on which the diagnostic efficacy of the above imaging agents in malignant cancers (renal cancer (especially clear cell renal cell carcinoma), lymphoma, or nasopharyngeal carcinoma (NPC)) will be evaluated.

Conditions

Renal Cancer; Renal Clear Cell Carcinoma; Lymphoma; Lymphoma, Large B-Cell, Diffuse; Follicular Lymphoma; Mantle Cell Lymphoma; Nasopharyngeal Carcinoma

Keywords

The cluster of differentiation (CD70); ImmunoPET; Renal Cancer; Lymphoma; Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (10)

• Standardized uptake value (SUV) of normal tissues and organs.

  Measurement of the overall biodistribution of the above tracers in normal tissues and organs (bladder (after voiding), background (pelvic fat), blood, brain, salivary and lacrimal glands, lung, liver, spleen, pancreas, small intestine, and kidneys). To calculate the SUV, circular regions of interest were drawn around the area of focally increased uptake in the transaxial slices and automatically fitted to a three-dimensional volume of interest.

  1 day from injection of the tracers

• SUV of tumors

  The SUV of the above tracers in the primary and/or metastatic lesions of the included subjects. To calculate the SUV, circular regions of interest were drawn around the area of focally increased uptake in the transaxial slices and automatically fitted to a three-dimensional volume of interest.

  1 day from injection of the tracers

• Radiation dosimetry of tissues/organs

  Measurement of absorbed radiation doses (Gy/MBq) to tissues/organs. The following tissues were included: adrenals, brain, breasts, gallbladder, small intestine, upper and lower large intestine, stomach, heart contents, heart muscle, kidney, liver, lung, muscle, ovaries, pancreas, red marrow, trabecular and cortical bone, spleen, testes, thymus, thyroid, urinary bladder, and uterus. Dynamic imaging within one hour will be performed for this purpose.

  1 day from injection of the tracers

• Radiation dosimetry of tumors

  Measurement of absorbed radiation doses (Gy/MBq) to tumors. Dynamic imaging within one hour will be performed for this purpose.

  1 day from injection of the tracers

• Radiation dosimetry of whole-body

  Whole-body activity was measured using a large volume of interest (VOI) covering the entire subject.

  1 day from injection of the tracers

• Diagnostic sensitivity

  Sensitivity = (True Positives) / (True Positives + False Negatives). The diagnostic value of CD70 immunoPET/CT will be compared with that of conventional imaging approaches, including 18F-FDG PET/CT, CT, and MRI.

  30 days

• Diagnostic specificity

  Specificity = (True Negatives) / (True Negatives + False Positives). The diagnostic value of CD70 immunoPET/CT will be compared with that of conventional imaging approaches, including 18F-FDG PET/CT, CT, and MRI.

  30 days

• Accuracy

  Accuracy = (True Positives + True Negatives) / (Total Tests). The diagnostic value of CD70 immunoPET/CT will be compared with that of conventional imaging approaches, including 18F-FDG PET/CT, CT, and MRI.

  30 days

• Positive Predictive Value (PPV)

  PPV = (True Positives) / (True Positives + False Positives). The diagnostic value of CD70 immunoPET/CT will be compared with that of conventional imaging approaches, including 18F-FDG PET/CT, CT, and MRI.

  30 days

• Negative Predictive Value (NPV)

  NPV = (True Negatives) / (True Negatives + False Negatives). The diagnostic value of CD70 immunoPET/CT will be compared with that of conventional imaging approaches, including 18F-FDG PET/CT, CT, and MRI.

  30 days

Secondary Outcomes (4)

• CD70 immunoPET/CT in altering initial staging for patients with renal cancer/lymphoma/NPC

  3-6 months

• CD70 immunoPET/CT for postoperative surveillance for patients with renal cancer/lymphoma/NPC

  3-6 months

• CD70 immunoPET/CT for restaging for patients with renal cancer/lymphoma/NPC

  3-6 months

• CD70 immunoPET/CT in evaluating treatment responses

  1-2 years

Study Arms (1)

CD70-targeted immunoPET imaging

EXPERIMENTAL

Enrolled patients will undergo a CD70-targeted immunoPET/CT scanning.

Drug: [18F]F-RESCA-RCCB6; Drug: [18F]F-RESCA-R8B4; Drug: [18F]F-RESCA-RD06; Drug: [68Ga]Ga-NOTA-R8B4; Drug: [68Ga]Ga-NOTA-RD06; Drug: [89Zr]Zr-DFO-RB6; Drug: [89Zr]Zr-DFO-R8B4; Drug: [89Zr]Zr-DFO-RD06

Interventions

[18F]F-RESCA-RCCB6 DRUG

Enrolled patients will receive 0.05-0.1 mCi/kg of \[18F\]RCCB6. ImmunoPET/CT imaging will be acquired 1-2 hours after \[18F\]RCCB6 injection.

Also known as: [18F]RCCB6

CD70-targeted immunoPET imaging

[18F]F-RESCA-R8B4 DRUG

Enrolled patients will receive 0.05-0.1 mCi/kg of \[18F\]R8B4. ImmunoPET/CT imaging will be acquired 1-2 hours after \[18F\]R8B4 injection.

Also known as: [18F]R8B4

CD70-targeted immunoPET imaging

[18F]F-RESCA-RD06 DRUG

Enrolled patients will receive 0.05-0.1 mCi/kg of \[18F\]RD06. ImmunoPET/CT imaging will be acquired 1-2 hours after \[18F\]RD06 injection.

Also known as: [18F]RD06

CD70-targeted immunoPET imaging

[68Ga]Ga-NOTA-R8B4 DRUG

Enrolled patients will receive 0.05-0.1 mCi/kg of \[68Ga\]R8B4. ImmunoPET/CT imaging will be acquired 1-2 hours after \[68Ga\]R8B4 injection.

Also known as: [68Ga]R8B4

CD70-targeted immunoPET imaging

[68Ga]Ga-NOTA-RD06 DRUG

Enrolled patients will receive 0.05-0.1 mCi/kg of \[68Ga\]RD06. ImmunoPET/CT imaging will be acquired 1-2 hours after \[68Ga\]RD06 injection.

Also known as: [68Ga]RD06

CD70-targeted immunoPET imaging

[89Zr]Zr-DFO-RB6 DRUG

Enrolled patients will receive a single dose (1-3 mCi) of \[89Zr\]Zr-DFO-RB6 (total 1-2 mg antibody mass). Multiple immunoPET/CT imaging sessions will be performed on day 0, day 1(24 h), day 3 (72 h), day 5 (120 h) or day 7 (168 h).

Also known as: [89Zr]RB6

CD70-targeted immunoPET imaging

[89Zr]Zr-DFO-R8B4 DRUG

Enrolled patients will receive a single dose (1-3 mCi) of \[89Zr\]Zr-DFO-R8B4 (total 1-2 mg antibody mass). Multiple immunoPET/CT imaging sessions will be performed on day 0, day 1(24 h), day 3 (72 h), day 5 (120 h) or day 7 (168 h).

Also known as: [89Zr]R8B4

CD70-targeted immunoPET imaging

[89Zr]Zr-DFO-RD06 DRUG

Enrolled patients will receive a single dose (1-3 mCi) of \[89Zr\]Zr-DFO-RD06 (total 1-2 mg antibody mass). Multiple immunoPET/CT imaging sessions will be performed on day 0, day 1(24 h), day 3 (72 h), day 5 (120 h) or day 7 (168 h).

Also known as: [89Zr]RD06

CD70-targeted immunoPET imaging

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-80 year-old and of either sex；
• Histologically confirmed diagnosis of renal cancer (especially ccRCC)/lymphoma/NPC or suspected renal cancer/lymphoma/NPC by diagnostic imaging;
• Capable of giving signed informed consent, including compliance with the requirements and restrictions in the informed consent form (ICF) and this protocol.

You may not qualify if:

• Pregnancy；
• Severe hepatic and renal insufficiency;
• Allergic to single-domain antibody radiopharmaceuticals.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, 200127, China

RECRUITING

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell; Lymphoma; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Follicular; Lymphoma, Mantle-Cell; Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• Jianjun Liu, Ph.D. & M.D.

  Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

  STUDY CHAIR

• Weijun Wei, Ph.D. & M.D.

  Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weijun Wei, Ph.D. & M.D.

CONTACT

15000083153; wwei@shsmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2025
• First Posted: February 28, 2025
• Study Start: December 23, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 28, 2025

Record last verified: 2025-02

Locations

CN (1)