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Enrolling by Invitation

NCT Number: NCT07101900

68Ga-NYM096 PET/ CT for the Detection of Clear Cell Renal Cell Carcinoma in Presurgical Patients With Renal Masses

This is a prospective, single-center, single-arm, diagnostic phase 2 study in patients who have renal masses scheduled for surgical resection. The goal is to determine the sensitivity and specificity of 68Ga-NYM096 PET/CT in the detection of clear cell renal cell carcinoma using histopathological diagnosis as ground truth, in patients with operable renal masses.

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Key information

Conditions

Clear Cell Renal Cell Carcinoma Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

About this study

This is a prospective, single-center, single-arm, diagnostic phase 2 study in patients with renal masses scheduled for surgical resection. Each patient will receive one dose of 68Ga-NYM096 by intravenous route. Dedicated whole-body PET/CT imaging will be performed. Additionally, prior to resection of the tumor, contrast-enhanced CT imaging of the abdomen, and if clinically warranted, or as part of the local standard of care, of the chest, will be performed. Both imaging modalities will be performed prior to resection of the kidney(s). PET/CT studies will be interpreted by two readers and diagnostic CT will be interpreted by one reader, all of whom will provide independent and blinded interpretations. Imaging interpretations and histopathologic evaluation data will be used to estimate the sensitivity, specificity, and predictive value (primary and secondary objectives) of each modality. The exploration into the detection of metastases by 68Ga-NYM096 PET/CT in comparison to diagnostic CT will also be performed.

The pathologist will identify representative tumor tissue for the determination of histology, grading, and CAIX expression.

100 patients will be recruited in Peking Union Medical College Hospital. This study will be conducted according to local regulations and laws, the ethical principles that have their origin in the Declaration of Helsinki, and the principles of Good Clinical Practice.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: ≥18 years;
  • Gender: No restriction;
  • Renal mass (solitary or multiple) with a maximum diameter ≥1 cm, confirmed by conventional imaging (ultrasound, non-contrast CT, contrast-enhanced CT, or MRI);
  • Scheduled for renal mass resection (partial or total nephrectomy, via open, laparoscopic, or robot-assisted techniques) within 1 month;
  • Life Expectancy:
  • At least 3 months, as assessed by a clinician;
  • ECOG Performance Status: 0-2;
  • Informed Consent: Provision of written informed consent;
  • Compliance: Willing and able to adhere to study procedures.

Exclusion criteria

  • Surgical Contraindications:
  • High anesthesia risk (ASA class ≥IV);
  • Severe cardiopulmonary dysfunction (NYHA class III-IV or FEV1 <50%);
  • Active bleeding or coagulation disorders (INR >1.5, platelets <80×10⁹/L).
  • Pregnancy/Lactation:
  • Pregnant (positive blood/urine HCG) or breastfeeding women;
  • childbearing potential without effective contraception.
  • Other Contraindications:
  • Claustrophobia;
  • Weight >150 kg ;
  • Alcohol allergy.
  • Any condition deemed by the investigator to interfere with study results or increase participant risk.

Treatment and study plan

68Ga-NYM096 PET/CT

Diagnostic Test

Participants will be administered a single, intravenous bolus of 68Ga-NYM096 The recommended administered activity of 68Ga-NYM096 is 1.8-2.2 MBq per kilogram bodyweight, subject to variation that may be required owing to variable elution efficiencies obtained during the lifetime of the 68Ga / 68Ga generator. The CT and PET imaging session will begin approximately 45 to 75 minutes after 68Ga-NYM096 administration.

Primary outcomes

  1. Histological classification of operated renal lesions

    Time frame: From study completion to 1 month after completion

    The histological classification of operated renal lesions will be determined according to WHO classification of tumors, Feb 2004.

  2. Binary reading of renal lesions identified on 68Ga-NYM096 PET/CT

    Time frame: From study completion to 1 month after completion

    Define lesion as PET positive or PET negative lesion. The kidney lesion is designated as positive if the SUVmax of kidney lesions is higher than that of liver (reference).

    Time Frame: From study completion to 1 month after completion

Secondary outcomes

  1. SUVmax of renal lesions identified on 68Ga-NYM096 PET/CT

    Time frame: From study completion to 1 month after completion

    For kidney lesions, the tracer uptake is quantified using maximal standard uptake value (SUVmax) by drawing a 3-dimensional region of interest (ROI) over the lesion using a threshold of 40% SUVmax. The ROI should be drawn with caution not to include any adjacent normal kidney parenchyma.

  2. Intensity of CAIX staining of operated renal lesions

    Time frame: From study completion to 1 month after completion

    The intensity of CAIX staining of operated renal lesions will be based on a 4-point scale from 0-3 according to the method of Bui et al, 2003

  3. SUVmax of liver uptake on 68Ga-NYM096 PET/CT

    Time frame: From study completion to 1 month after completion

    The liver uptake (SUVmax) is used as the references to define PET positive lesions. It is measured by placing a 3-cm region of interest in right lobe at the level of porta hepatis. Focal lesion should be avoided if present.

  4. Tumor grade of operated renal lesions

    Time frame: From study completion to 1 month after completion

    The tumor grade of operated renal lesions will be determined according to Fuhrmann grading system

  5. Binary reading of renal lesions identified on diagnostic CT

    Time frame: From study completion to 1 month after completion

    A tumor will be described as clear cell renal carcinoma on a triphasic CT if one of the following two parameters is applicable: Significant (>85 HU) enhancement in the cortico-medullary phase Significant (>45 HU) enhancement in the parenchyma / excretory phase

  6. Size of renal lesions identified on diagnostic CT

    Time frame: From study completion to 1 month after completion

    The longest diameter of the tumor will be measured on diagnostic CT

  7. Number of metastatic lesions identified on 68Ga-NYM096 PET/CT

    Time frame: From study completion to 1 month after completion

    For metastasis evaluation, any focal accumulation of 68Ga-NYM096 outside the kidneys that cannot be explained by physiologic uptake is interpreted as focal lesion. The SUVmax and tumor-to-background should be evaluated. Surrounding tissue is the preferred background tissue. Should not available, the blood pool should be designated as background tissue. Any focal lesion identified on 68Ga-NYM096 PET will be considered to be positive for metastasis if SUVmax (lesion) is no less than SUVmax (liver) or tumor-to-background ratio is higher than 1.

  8. Location of metastatic lesions identified on 68Ga-NYM096 PET/CT

    Time frame: From study completion to 1 month after completion

    For metastasis evaluation, any focal accumulation of 68Ga-NYM096 outside the kidneys that cannot be explained by physiologic uptake is interpreted as focal lesion. The SUVmax and tumor-to-background should be evaluated. Surrounding tissue is the preferred background tissue. Should not available, the blood pool should be designated as background tissue. Any focal lesion identified on 68Ga-NYM096 PET will be considered to be positive for metastasis if SUVmax (lesion) is no less than SUVmax (liver) or tumor-to-background ratio is higher than 1.

  9. Size of metastatic lesions identified on 68Ga-NYM096 PET/CT

    Time frame: From study completion to 1 month after completion

    For metastasis evaluation, any focal accumulation of 68Ga-NYM096 outside the kidneys that cannot be explained by physiologic uptake is interpreted as focal lesion. The SUVmax and tumor-to-background should be evaluated. Surrounding tissue is the preferred background tissue. Should not available, the blood pool should be designated as background tissue. Any focal lesion identified on 68Ga-NYM096 PET will be considered to be positive for metastasis if SUVmax (lesion) is no less than SUVmax (liver) or tumor-to-background ratio is higher than 1.

  10. Number of metastatic lesions identified on diagnostic CT

    Time frame: From study completion to 1 month after completion

    The number of metastatic lesions on diagnostic CT will be determined by radiologist according to the typical location, enhancement pattern of the lesions.

  11. Location of metastatic lesions on diagnostic CT

    Time frame: From study completion to 1 month after completion

    The location of metastatic lesions on diagnostic CT will be determined by radiologist according to the typical location, enhancement pattern of the lesions.

  12. Size of metastatic lesions on diagnostic CT

    Time frame: From study completion to 1 month after completion

    The size of metastatic lesions on diagnostic CT will be measured by radiologist according to the typical location, enhancement pattern of the lesions.

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

68Ga-NYM096 PET/CT for the Detection of Clear Cell Renal Cell Carcinoma in Presurgical Patients With Renal Masses

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 3, 2025
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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